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1.
Biology (Basel) ; 11(11)2022 Nov 01.
Article En | MEDLINE | ID: mdl-36358298

Background: We initiated a prospective screening trial in patients with hepatitis to diagnose HCC in the early stage and to evaluate the impact on long-term survival. Methods: From 1993−2006, 10,372 patients with chronic hepatitis B (14%), hepatitis C (81%), or both (5%) were enrolled in an HCC screening program. All patients underwent liver biopsy at enrollment. Transabdominal ultrasonography and serum alpha-fetoprotein were evaluated every 6 months. Abnormal screening results led to axial imaging and tumor biopsy. Results: Cirrhosis was confirmed on biopsy in 2074 patients (20%). HCC was diagnosed in 1016 patients (9.8%), all of whom had cirrhosis (49.0% HCC incidence in patients with cirrhosis). HCC was diagnosed at the initial screening in 165 patients (16.2%) and on follow-up in 851 patients (83.8%). The HCC diagnosis median time during follow-up screening was 6 years (range 4−10). Curative-intent treatment (resection, ablation, or transplant) was performed in 713 patients (70.2%). Overall survival at 5 and 10 years in those 713 patients was 30% and 4%, respectively, compared to no 5-year survivors in the 303 patients with advanced-stage disease (p < 0.001). Cause of death at 5 years in the 713 patients treated with curative intent was HCC in 371 patients (52%), progressive cirrhosis in 116 patients (16%), and other causes in 14 patients (2%). At 10 years, 456 patients (64%) had died from HCC, 171 (24%) from progressive cirrhosis, and 57 (8%) from other causes. Conclusions: Our screening program diagnosed early-stage HCC, permitting curative-intent treatment in 70%, but the 10-year survival rate is 4% due to HCC recurrence and progressive cirrhosis.

2.
Am J Surg ; 224(1 Pt B): 635-640, 2022 07.
Article En | MEDLINE | ID: mdl-35249728

BACKGROUND: Return to Intended Oncologic Treatment (RIOT) has been proposed as a quality metric in the care of cancer patients. We sought to define factors associated with inability to RIOT in Pancreatic Ductal Adenocarcinoma (PDAC) patients. METHODS: The NCDB was queried for patients who underwent pancreaticoduodenectomy for pathologic stage IB, IIA, or IIB PDAC from 2010 to 2016. Multivariable binary logistic regression models identified factors associated with failure to RIOT, and Kaplan-Meier survival analysis and Cox multivariable regression models demonstrated the impact of failure to RIOT on survival. RESULTS: Increasing age (p < .001), Hispanic race (p = .002), pathological stage IB (p = .004) and IIA (p = .001) as compared to IIB, increasing hospital stay (p < .001), and open surgical approach (p = .024) were associated with increased risk of inability to RIOT. Male sex (p < .001), Charlson-Deyo scores of 0 (p < .001) and 1 (p = .001) as compared to >2, negative surgical margins (p = .048), receiving care at academic institutions (p = .001), and increasing institutional case volume (p = .001) were associated with improved odds of RIOT. CONCLUSIONS: Patient features can impact RIOT and should be considered when designing multi-modality treatment strategies.


Carcinoma, Pancreatic Ductal , Pancreatic Neoplasms , Carcinoma, Pancreatic Ductal/surgery , Humans , Male , Pancreatectomy , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy , Retrospective Studies , Pancreatic Neoplasms
3.
J Surg Res ; 256: 374-380, 2020 12.
Article En | MEDLINE | ID: mdl-32739621

BACKGROUND: Safety net hospitals have historically cared for a disproportionate number of patients of low socioeconomic status, racial and ethnic minorities, and patients with cancer. These innate challenges make safety net hospitals important in understanding how to improve access to cancer care in order to fit the needs of vulnerable patients and ultimately improve their outcomes. The purpose of this study is to characterize the current state and treatment of hepatocellular carcinoma (HCC) at Ben Taub Hospital, a safety net hospital in Houston, Texas. MATERIALS AND METHODS: A retrospective chart review was performed to review the demographic characteristics, clinicopathologic data, treatment strategies, and outcomes of HCC patients at Ben Taub Hospital between January 2012 and December 2014. RESULTS: Two-hundred twenty-six men and 78 women with a mean age of 58 y underwent evaluation. Most (87%) were either uninsured or covered by Medicaid. The majority (69%) of patients presented with advanced (stage 2 or more) disease, with 58% of patients presenting with multiple lesions. Of the 40% that presented with a solitary lesion, the average size was 4.97 cm. Transarterial chemoembolization was used in 37% of patients and sorafenib was given to 26% of patients. Five patients underwent successful transplant. One hundred seventeen (38%) patients died of their disease, 25 patients are alive with no evidence of disease, and 159 patients have been lost to follow-up. CONCLUSIONS: Most patients with HCC presented to this safety net hospital with advanced disease; however, multiple local and systemic treatments were offered. Screening programs to detect HCC at an earlier stage are essential for successful long-term outcomes in a resource-strapped hospital with limited access to liver transplantation.


Carcinoma, Hepatocellular/diagnosis , Health Services Accessibility/statistics & numerical data , Liver Neoplasms/diagnosis , Mass Screening/organization & administration , Safety-net Providers/statistics & numerical data , Carcinoma, Hepatocellular/economics , Carcinoma, Hepatocellular/mortality , Carcinoma, Hepatocellular/therapy , Chemoembolization, Therapeutic/economics , Chemoembolization, Therapeutic/statistics & numerical data , Disease-Free Survival , Female , Follow-Up Studies , Health Services Accessibility/economics , Health Services Needs and Demand/statistics & numerical data , Humans , Liver/pathology , Liver Neoplasms/economics , Liver Neoplasms/mortality , Liver Neoplasms/therapy , Liver Transplantation/economics , Liver Transplantation/statistics & numerical data , Male , Middle Aged , Minority Groups/statistics & numerical data , Neoplasm Staging/economics , Retrospective Studies , Safety-net Providers/organization & administration , Socioeconomic Factors , Sorafenib/economics , Sorafenib/therapeutic use
4.
J Surg Educ ; 77(5): 1082-1087, 2020.
Article En | MEDLINE | ID: mdl-32505672

OBJECTIVE: Surgeon-scientists are becoming increasingly scarce, and therefore, engaging residents in research during their training is important. We evaluated whether a multifaceted research engagement program was associated with increased academic productivity of general surgery residents. DESIGN: Our research engagement program has 4 pillars: A research requirement, a structured research curriculum, infrastructure to support residents' research, and an annual resident research day to highlight trainees' work. We compared the number of manuscripts published per chief resident during the 4 years before and after program implementation in 2013. We performed subgroup analyses to examine productivity of research track residents and clinical track residents. SETTING: A general surgery residency program in an academic setting. PARTICIPANTS: The participants were 57 general surgery residents (23 research track and 34 clinical track) graduating between 2010 and 2017. RESULTS: There was a significant increase in overall research productivity, with 28 chief residents publishing an average of 2.3 ± 1.0 manuscripts before and 29 chief residents publishing an average of 8.5 ± 3.2 manuscripts after program implementation (p = 0.01). Research track residents had a nonsignificant increase in publications from an average of 6.3 ± 3.1 before to 15.4 ± 8.9 after the new program (p = 0.10). Clinical track residents had a significant increase in publications from a median of 0.9 (interquartile range: 0.5, 1.0) before to a median of 1.3 (interquartile range: 1.2, 8.6) after the new program (p = 0.03). CONCLUSIONS: Implementation of a multifaceted research engagement program was associated with a significant increase in manuscripts published by general surgery residents, including clinical track residents. Components of our program may be of use to other programs looking to improve resident research engagement and productivity.


General Surgery , Internship and Residency , Curriculum , Education, Medical, Graduate , Efficiency , General Surgery/education , Humans
5.
Am J Hosp Palliat Care ; 37(1): 12-18, 2020 Jan.
Article En | MEDLINE | ID: mdl-31122027

BACKGROUND: Prospective, randomized trials are needed to determine optimal treatment approaches for palliative care problems such as malignant bowel obstruction (MBO). Randomization poses unique issues for such studies, especially with divergent treatment approaches and varying levels of equipoise. We report our experience accruing randomized patients to the Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (SWOG S1316) study, comparing surgical and nonsurgical management of MBO. METHODS: Patients with MBO who were surgical candidates and had treatment equipoise were accrued and offered randomization to surgical or nonsurgical management. Patients choosing nonrandomization were offered prospective observation. Trial details are listed on www.clinicaltrials.gov (NCT #02270450). An accrual algorithm was developed to enhance enrollment. RESULTS: Accrual is ongoing with 176 patients enrolled. Most (89%) patients chose nonrandomization, opting for nonsurgical management. Of 25 sites that have accrued to this study, 6 enrolled patients on the randomization arm. Approximately 59% (20/34) of the randomization accrual goal has been achieved. Patient-related factors and clinician bias have been the most prevalent reasons for lack of randomization. An algorithm was developed from clinician experience to aid randomization. Using principles in this tool, repeated physician conversations discussing treatment options and goals of care, and a supportive team-approach has helped increase accrual. CONCLUSIONS: Experience gained from the S1316 study can aid future palliative care trials. Although difficult, it is possible to randomize patients to palliative studies by giving clinicians clear recommendations utilizing an algorithm of conversation, allotment of necessary time to discuss the trial, and encouragement to overcome internal bias.


Intestinal Obstruction/etiology , Intestinal Obstruction/therapy , Neoplasms/complications , Palliative Care/organization & administration , Research Design , Algorithms , Humans , Intestinal Obstruction/surgery , Neoplasms/pathology , Patient Selection , Prospective Studies
6.
J Surg Res ; 247: 547-555, 2020 03.
Article En | MEDLINE | ID: mdl-31740011

BACKGROUND: With advances in cross-sectional imaging, pancreatic cysts are more frequently diagnosed and have become a common indication for pancreatectomy. The impact of pancreatectomy in these patients is important. The purpose of this study was to assess short-term outcomes, long-term nutritional status, quality of life (QOL), and pancreas function after pancreatectomy for cystic neoplasms. MATERIALS AND METHODS: At a single institution, patients at least 3 y post-pancreatectomy for benign cystic neoplasms were identified. Using a validated questionnaire, short-term outcomes, long-term outcomes including endocrine and exocrine insufficiency, long-term nutritional status, and preoperative and postoperative QOL were compared based on operation and indication for resection. RESULTS: Among 102 eligible patients, 70 had valid contact information and 51 (72.9%) agreed to participate. Median follow-up was 6 (4-8) y. Patients undergoing pancreatoduodenectomy for benign cysts had higher morbidity than a similar cohort resected for pancreatic adenocarcinoma (patients with at least 1 ≥ grade 2 complication [49.0% versus 31.6%, P = 0.038]). After long-term follow-up, pancreatectomy did not significantly affect perceived QOL. Half of patients had mild-moderate or severe malnourishment, but pancreatic enzyme replacement was reported by only 4 (7.8%) patients. New-onset diabetes was present in 15 (29.4%) patients with median time-to-diagnosis of 6 (1-12) mo after resection. CONCLUSIONS: Pancreatectomy for benign cysts did not negatively impact patients' perceived QOL. However, after long-term follow-up, malnutrition and pancreatic insufficiency occurred in a significant percentage and may be greater than previously estimated. Consideration of short- and long-term outcomes should factor into preoperative counseling, especially in cysts with minimal risk of progression to malignancy.


Carcinoma, Pancreatic Ductal/surgery , Pancreatic Cyst/surgery , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Aged , Female , Follow-Up Studies , Humans , Male , Middle Aged , Nutritional Status , Patient Reported Outcome Measures , Postoperative Complications/etiology , Prospective Studies , Quality of Life , Treatment Outcome
7.
J Surg Res ; 236: 144-152, 2019 04.
Article En | MEDLINE | ID: mdl-30694749

BACKGROUND: Identification of incidental pancreatic lesions is increasing because of advancements in imaging. Diagnosis remains a challenge for clinicians, with intrapancreatic accessory spleens (IPAS) posing a unique dilemma. IPAS are frequently resected because of inability to exclude alternate diagnoses, subjecting patients to unnecessary risk. The purpose of this study was to examine our institutional experience with IPAS and develop a multidisciplinary algorithm to improve preoperative diagnosis. MATERIALS AND METHODS: Patients who underwent a distal pancreatectomy at a single institution from 2005 to 2018 were identified from a prospectively maintained database. Examination of final pathology for a diagnosis of IPAS yielded the final cohort. Demographics, preoperative workup, and operative course were reviewed and analyzed. A diagnostic algorithm was composed based on the consensus of a panel of expert pancreatic surgeons, a radiologist, and a pathologist. RESULTS: Ten patients of 303 patients who underwent a distal pancreatectomy were identified with a final pathology of IPAS. The average age was 54 y, 80% were white, and 60% were male. Lesions ranged in size from 7 mm to 5.1 cm in largest diameter (mean 2.2 cm). Lesions were described as round, well-marginated, and enhancing masses within the pancreatic tail. Preoperative workup was variable in terms of imaging and laboratory testing. Diagnostic workups were examined and combined with multidisciplinary input to create a diagnostic algorithm. CONCLUSIONS: Incidental pancreatic lesions like IPAS remain a diagnostic challenge for clinicians. Employing a diagnostic algorithm as proposed may aid in the distinction of malignant and premalignant pathology and prevent unwarranted pancreatic resections.


Choristoma/diagnosis , Clinical Protocols , Incidental Findings , Pancreatic Diseases/diagnosis , Spleen , Adult , Aged , Choristoma/pathology , Choristoma/surgery , Diagnosis, Differential , Female , Humans , Male , Middle Aged , Pancreatectomy , Pancreatic Diseases/pathology , Pancreatic Diseases/surgery , Pathologists/organization & administration , Patient Care Team/organization & administration , Prospective Studies , Radiologists/organization & administration , Retrospective Studies , Surgeons/organization & administration , Tomography, X-Ray Computed
8.
J Surg Res ; 236: 332-339, 2019 04.
Article En | MEDLINE | ID: mdl-30694774

BACKGROUND: Early drain removal when postoperative day (POD) one drain fluid amylase (DFA) was ≤5000 U/L reduced complications in a previous randomized controlled trial. We hypothesized that most surgeons continue to remove drains late and this is associated with inferior outcomes. METHODS: We assessed the practice of surgeons in a prospectively maintained pancreas surgery registry to determine the association between timing of drain removal with demographics, comorbidities, and complications. We selected patients with POD1 DFA ≤5000 U/L and excluded those without drains, and subjects without data on POD1 DFA or timing of drain removal. Early drain removal was defined as ≤ POD5. RESULTS: Two hundred and forty four patients met inclusion criteria. Only 90 (37%) had drains removed early. Estimated blood loss was greater in the late removal group (190 mL versus 100 mL, P = 0.005) and pathological findings associated with soft gland texture were more frequent (97 [63%] versus 35 [39%], P < 0.0001). Patients in the late drain removal group had more complications (84 [55%] versus 30 [33%], P = 0.001) including pancreatic fistula (55 [36%] versus 4 [4%], P < 0.0001), delayed gastric emptying (27 [18%] versus 3 [3%], P = 0.002), and longer length of stay (7 d versus 5 d, P < 0.0001). In subset analysis for procedure type, complications and pancreatic fistula remained significant for both pancreatoduodenectomy and distal pancreatectomy. CONCLUSIONS: Despite level one data suggesting improved outcomes with early removal when POD1 DFA is ≤ 5000 U/L, experienced pancreas surgeons more frequently removed drains late. This practice was associated with known risk factors (estimated blood loss, soft pancreas) and may be associated with inferior outcomes suggesting potential for improvement.


Drainage/methods , Evidence-Based Medicine/methods , Postoperative Care/methods , Postoperative Complications/prevention & control , Practice Patterns, Physicians'/statistics & numerical data , Aged , Amylases/analysis , Female , Humans , Incidence , Male , Middle Aged , Pancreatectomy/adverse effects , Pancreaticoduodenectomy/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Registries/statistics & numerical data , Risk Factors , Time Factors , Treatment Outcome
9.
Am J Surg ; 218(1): 225-229, 2019 07.
Article En | MEDLINE | ID: mdl-30665613

BACKGROUND: Implementation of resident duty hour policies has resulted in a need to document work hours accurately. We compared the number of self-reported duty hour violations identified through an anonymous, resident-administered survey to that obtained from a standardized, ACGME-sanctioned electronic tracking system. METHODS: 10 cross-sectional surveys were administered to general surgery residents over five years. A resident representative collected and de-identified the data. RESULTS: A median of 54 residents (52% male) participated per cohort. 429 responses were received (79% response rate). 111 violations were reported through the survey, while the standardized electronic system identified 76, a trend significantly associated with PGY-level (p < 0.001) and driven by first-year residents (n = 81 versus 37, p = 0.001). CONCLUSIONS: An anonymous, resident-run mechanism identifies significantly more self-reported violations than a standardized electronic tracking system alone. This argues for individual program evaluation of duty hour tracking mechanisms to correct systematic issues that could otherwise lead to repeated violations.


Internship and Residency , Self Report , Workload/statistics & numerical data , Female , Humans , Male , Organizational Policy , Personnel Staffing and Scheduling , Surveys and Questionnaires , United States , Young Adult
10.
Surgery ; 165(2): 307-314, 2019 02.
Article En | MEDLINE | ID: mdl-30243481

BACKGROUND: Although current guidelines recommend multimodal therapy for all patients with pancreatic ductal adenocarcinoma, it is unclear the extent to which clinical stage I patients are accurately staged and how this may affect management. METHODS: In this retrospective cohort study of 4,404 patients aged 18-79 years with clinical stage 1 (ie, T1N0 or T2N0) pancreatic ductal adenocarcinoma treated with upfront resection in the National Cancer Database (2004-2014), understaging was ascertained by comparing pretreatment clinical stage with pathologic stage. The association between adjuvant treatment and overall risk of death among true stage I and understaged patients was evaluated using multivariable Cox regression. RESULTS: Upstaging was identified in 72.6% of patients (62.8% T3/4, 53.9% N1) of whom 69.7% received adjuvant therapy compared with 47.0% with true stage I disease. Overall survival at 5 years among those with true stage I disease was significantly higher than those who had been clinically understaged (42.9% vs 16.6%; log-rank, p < 0.001). For true stage I patients, adjuvant therapy was not associated with risk of death (hazard ratio: 1.07, 95% confidence interval: 0.89-1.29). For understaged patients, adjuvant therapy significantly decreased risk of death (hazard ratio: 0.64, 95% confidence interval: 0.55-0.74). CONCLUSION: The majority of clinical stage I pancreatic ductal adenocarcinoma patients actually have higher-stage disease and benefit from multimodal therapy; however, one third of understaged patients do not receive any adjuvant treatment. Clinicians should discuss all potential treatment strategies with patients (in the context of the acknowledged risks and benefits), including the utilization of neoadjuvant approaches in those presenting with potentially resectable disease.


Carcinoma, Pancreatic Ductal/pathology , Carcinoma, Pancreatic Ductal/therapy , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/therapy , Aged , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Pancreatic Ductal/mortality , Chemotherapy, Adjuvant , Cohort Studies , Female , Humans , Male , Middle Aged , Pancreatic Neoplasms/mortality , Radiotherapy, Adjuvant , Registries , Retrospective Studies
11.
J Surg Res ; 228: 271-280, 2018 08.
Article En | MEDLINE | ID: mdl-29907222

BACKGROUND: Addition of en bloc segmental venous reconstruction (VR) to pancreaticoduodenectomy (PD) for venous involvement of pancreatic tumors increases the complexity of the operation and may increase complications. The long-term mesenteric venous patency rate and oncologic outcome has not been well defined. METHODS: Our prospective database was reviewed to assess 90-day postoperative outcomes for patients who underwent PD or PD + VR (September 2004-June 2016). Two independent observers reviewed CT scans to determine long-term vein patency. In patients with pancreatic ductal adenocarcinoma, the impact of VR on 5-year overall survival was assessed using multivariate Cox proportional hazards regression. Student's t-test was used to evaluate continuous variables and the chi-square test for categorical variables. RESULTS: Three hundred ninety-three patients underwent PD (51 PD + VR). Patients undergoing PD + VR had longer operations (561 ± 119 versus 433 ± 89 min, P < 0.00001) and greater blood loss (768 ± 812 versus 327 ± 423 cc, P < 0.00001). There was no difference in 90-day mortality, overall postoperative complication rates, complication severity grades, reoperation, readmission, or length of stay. 26.7% experienced venous thrombosis. Most thromboses occurred in the first year after surgery, but we also observed late thrombosis in 1 patient after 89-month follow-up. Among 135 patients with pancreatic ductal adenocarcinoma, survival was significantly longer in the PD-alone group (31.3 months [95% confidence interval: 22.9-40.0] versus 17.0 [95% confidence interval: 13.0-19.1], plog-rank = 0.013). CONCLUSIONS: PD + VR does not increase short-term morbidity, but venous thrombosis is frequent and can occur long after surgery. Survival is inferior when VR is required especially in the absence of neoadjuvant chemotherapy.


Carcinoma, Pancreatic Ductal/surgery , Mesenteric Veins/surgery , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Plastic Surgery Procedures/adverse effects , Postoperative Complications/epidemiology , Venous Thrombosis/epidemiology , Aged , Anastomosis, Surgical/adverse effects , Anastomosis, Surgical/methods , Blood Loss, Surgical/statistics & numerical data , Carcinoma, Pancreatic Ductal/mortality , Female , Follow-Up Studies , Hospital Mortality , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Pancreatic Neoplasms/mortality , Pancreaticoduodenectomy/methods , Patient Readmission/statistics & numerical data , Postoperative Complications/etiology , Prospective Studies , Plastic Surgery Procedures/methods , Reoperation/statistics & numerical data , Retrospective Studies , Survival Analysis , Tomography, X-Ray Computed , Treatment Outcome , Vascular Patency , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/etiology
12.
HPB (Oxford) ; 20(6): 514-520, 2018 06.
Article En | MEDLINE | ID: mdl-29478737

BACKGROUND: Although used as criterion for early drain removal, postoperative day (POD) 1 drain fluid amylase (DFA) ≤ 5000 U/L has low negative predictive value for clinically relevant postoperative pancreatic fistula (CR-POPF). It was hypothesized that POD3 DFA ≤ 350 could provide further information to guide early drain removal. METHODS: Data from a pancreas surgery consortium database for pancreatoduodenectomy and distal pancreatectomy patients were analyzed retrospectively. Those patients without drains or POD 1 and 3 DFA data were excluded. Patients with POD1 DFA ≤ 5000 were divided into groups based on POD3 DFA: Group A (≤350) and Group B (>350). Operative characteristics and 60-day outcomes were compared using chi-square test. RESULTS: Among 687 patients in the database, all data were available for 380. Fifty-five (14.5%) had a POD1 DFA > 5000. Among 325 with POD1 DFA ≤ 5000, 254 (78.2%) were in Group A and 71 (21.8%) in Group B. Complications (35 (49.3%) vs 87 (34.4%); p = 0.021) and CR-POPF (13 (18.3%) vs 10 (3.9%); p < 0.001) were more frequent in Group B. CONCLUSIONS: In patients with POD1 DFA ≤ 5000, POD3 DFA ≤ 350 may be a practical test to guide safe early drain removal. Further prospective testing may be useful.


Amylases/metabolism , Clinical Enzyme Tests , Device Removal/methods , Drainage/instrumentation , Pancreatectomy , Pancreaticoduodenectomy , Time-to-Treatment , Adult , Aged , Biomarkers/metabolism , Databases, Factual , Device Removal/adverse effects , Drainage/adverse effects , Female , Humans , Male , Middle Aged , Pancreatectomy/adverse effects , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Pancreaticoduodenectomy/adverse effects , Predictive Value of Tests , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
13.
Pancreas ; 47(1): 12-17, 2018 01.
Article En | MEDLINE | ID: mdl-29232341

Many pancreatic surgeons continue to use intraperitoneal drains, but others have limited or avoided their use, believing this improves outcomes. We conducted a systematic review and meta-analysis of the literature assessing outcomes in pancreatectomy without drains, selective drainage, and early drain removal. We searched PubMed, Embase, and the Cochrane Library databases and conducted a systematic review of randomized and nonrandomized studies comparing routine intra-abdominal drainage versus no drainage, selective drain use, and early versus late drain removal after pancreatectomy, with major complications as the primary outcome. A meta-analysis of the literature assessing routine use of drains was conducted using the random-effects model. A total of 461 articles met search criteria from PubMed (168 articles), Embase (263 articles), and the Cochrane Library (30 articles). After case reports and articles without primary data on complications were excluded, 14 studies were identified for systematic review. Definitive evidence-based recommendations cannot be made regarding the management of drains following pancreatectomy because of limitations in the available literature. Based on available evidence, the most conservative approach, pending further data, is routine placement of a drain and early removal unless the patient's clinical course or drain fluid amylase concentration suggests a developing fistula.


Drainage/methods , Evidence-Based Practice/methods , Pancreatectomy/methods , Postoperative Complications/therapy , Device Removal , Drainage/adverse effects , Drainage/instrumentation , Humans , Pancreatectomy/adverse effects , Postoperative Complications/etiology , Randomized Controlled Trials as Topic , Treatment Outcome
14.
Ann Surg ; 266(3): 421-431, 2017 09.
Article En | MEDLINE | ID: mdl-28692468

OBJECTIVE: The objective of this study was to test the hypothesis that distal pancreatectomy (DP) without intraperitoneal drainage does not affect the frequency of grade 2 or higher grade complications. BACKGROUND: The use of routine intraperitoneal drains during DP is controversial. Prior to this study, no prospective trial focusing on DP without intraperitoneal drainage has been reported. METHODS: Patients undergoing DP for all causes at 14 high-volume pancreas centers were preoperatively randomized to placement of a drain or no drain. Complications and their severity were tracked for 60 days and mortality for 90 days. The study was powered to detect a 15% positive or negative difference in the rate of grade 2 or higher grade complications. All data were collected prospectively and source documents were reviewed at the coordinating center to confirm completeness and accuracy. RESULTS: A total of 344 patients underwent DP with (N = 174) and without (N = 170) the use of intraperitoneal drainage. There were no differences between cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, or operative technique. There was no difference in the rate of grade 2 or higher grade complications (44% vs. 42%, P = 0.80). There was no difference in clinically relevant postoperative pancreatic fistula (18% vs 12%, P = 0.11) or mortality (0% vs 1%, P = 0.24). DP without routine intraperitoneal drainage was associated with a higher incidence of intra-abdominal fluid collection (9% vs 22%, P = 0.0004). There was no difference in the frequency of postoperative imaging, percutaneous drain placement, reoperation, readmission, or quality of life scores. CONCLUSIONS: This prospective randomized multicenter trial provides evidence that clinical outcomes are comparable in DP with or without intraperitoneal drainage.


Drainage , Pancreatectomy/methods , Postoperative Complications/prevention & control , Aged , Drainage/methods , Female , Follow-Up Studies , Humans , Male , Middle Aged , Outcome Assessment, Health Care , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies
15.
Surgery ; 162(3): 557-567, 2017 09.
Article En | MEDLINE | ID: mdl-28666686

BACKGROUND: Multimodal therapy is recommended for early stage pancreatic cancer, although whether all patients benefit and the optimal timing of chemotherapy remain unclear. METHODS: Retrospective cohort study of patients aged 18-79 years with stage I-II pancreatic ductal adenocarcinoma in the National Cancer Database (2004-2012). Patients were grouped based on treatment strategy as surgery only, adjuvant, and preoperative. Accuracy of nodal staging and rate of nodal downstaging were ascertained using pretreatment clinical and postresection pathologic nodal status data. Association between overall risk of death and treatment strategy was evaluated with multivariable Cox regression. RESULTS: Among 19,031 patients, 31.1% underwent surgery only, 59.6% received adjuvant, and 9.3% preoperative therapy. Based on patients receiving upfront surgery, clinical nodal staging bore sensitivity, specificity, positive predictive value, and negative predictive value of 46.2%, 95.7%, 95.1%, and 49.8%, respectively. Preoperative therapy downstaged 38% of cN1 patients to ypN0; 5-year overall survival for this group was 27.2% vs 12.3% for ypN1 patients (P < .001). Relative to surgery only, adjuvant (HR 0.75, 95% CI [0.71-0.78]) and preoperative therapy (HR 0.66 [0.60-0.73]) were associated with lower risk of death among patients with pN1, but not pN0 (adjuvant-HR 1.01 [0.94-1.09]; preoperative-HR 1.10 [0.99-1.22]), disease. CONCLUSION: Our data provide strong support for preoperative chemotherapy for patients with node-positive pancreatic cancer, one third of whom may be downstaged. Among those with seemingly node-negative disease, half will be understaged with current clinical staging modalities. These results should be considered when planning treatment for patients with early stage pancreatic cancer.


Adenocarcinoma/pathology , Adenocarcinoma/therapy , Lymph Nodes/pathology , Pancreatectomy/methods , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/therapy , Adenocarcinoma/mortality , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Chemotherapy, Adjuvant , Cohort Studies , Combined Modality Therapy , Confidence Intervals , Disease-Free Survival , Humans , Lymph Node Excision/methods , Lymphatic Metastasis , Male , Middle Aged , Neoadjuvant Therapy/methods , Neoplasm Invasiveness/pathology , Neoplasm Staging , Pancreatectomy/mortality , Pancreatic Neoplasms/mortality , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Survival Analysis , Treatment Outcome
16.
World J Gastrointest Surg ; 9(3): 73-81, 2017 Mar 27.
Article En | MEDLINE | ID: mdl-28396720

AIM: To characterize incidence and risk factors for delayed gastric emptying (DGE) following pancreaticoduodenectomy and examine its implications on healthcare utilization. METHODS: A prospectively-maintained database was reviewed. DGE was classified using International Study Group of Pancreatic Surgery criteria. Patients who developed DGE and those who did not were compared. RESULTS: Two hundred and seventy-six patients underwent pancreaticoduodenectomy (PD) (> 80% pylorus-preserving, antecolic-reconstruction). DGE developed in 49 patients (17.8%): 5.1% grade B, 3.6% grade C. Demographic, clinical, and operative variables were similar between patients with DGE and those without. DGE patients were more likely to present multiple complications (32.6% vs 4.4%, ≥ 3 complications, P < 0.001), including postoperative pancreatic fistula (POPF) (42.9% vs 18.9%, P = 0.001) and intra-abdominal abscess (IAA) (16.3% vs 4.0%, P = 0.012). Patients with DGE had longer hospital stay (median, 12 d vs 7 d, P < 0.001) and were more likely to require transitional care upon discharge (24.5% vs 6.6%, P < 0.001). On multivariate analysis, predictors for DGE included POPF [OR = 3.39 (1.35-8.52), P = 0.009] and IAA [OR = 1.51 (1.03-2.22), P = 0.035]. CONCLUSION: Although DGE occurred in < 20% of patients after PD, it was associated with increased healthcare utilization. Patients with POPF and IAA were at risk for DGE. Anticipating DGE can help individualize care and allocate resources to high-risk patients.

17.
Nutrients ; 9(3)2017 Mar 07.
Article En | MEDLINE | ID: mdl-28272344

Pancreatic cancer is an aggressive malignancy with a poor prognosis. The disease and its treatment can cause significant nutritional impairments that often adversely impact patient quality of life (QOL). The pancreas has both exocrine and endocrine functions and, in the setting of cancer, both systems may be affected. Pancreatic exocrine insufficiency (PEI) manifests as weight loss and steatorrhea, while endocrine insufficiency may result in diabetes mellitus. Surgical resection, a central component of pancreatic cancer treatment, may induce or exacerbate these dysfunctions. Nutritional and metabolic dysfunctions in patients with pancreatic cancer lack characterization, and few guidelines exist for nutritional support in patients after surgical resection. We reviewed publications from the past two decades (1995-2016) addressing the nutritional and metabolic status of patients with pancreatic cancer, grouping them into status at the time of diagnosis, status at the time of resection, and status of nutritional support throughout the diagnosis and treatment of pancreatic cancer. Here, we summarize the results of these investigations and evaluate the effectiveness of various types of nutritional support in patients after pancreatectomy for pancreatic adenocarcinoma (PDAC). We outline the following conservative perioperative strategies to optimize patient outcomes and guide the care of these patients: (1) patients with albumin < 2.5 mg/dL or weight loss > 10% should postpone surgery and begin aggressive nutrition supplementation; (2) patients with albumin < 3 mg/dL or weight loss between 5% and 10% should have nutrition supplementation prior to surgery; (3) enteral nutrition (EN) should be preferred as a nutritional intervention over total parenteral nutrition (TPN) postoperatively; and, (4) a multidisciplinary approach should be used to allow for early detection of symptoms of endocrine and exocrine pancreatic insufficiency alongside implementation of appropriate treatment to improve the patient's quality of life.


Metabolic Diseases/physiopathology , Nutritional Support , Pancreatic Neoplasms/physiopathology , Biomarkers/blood , Biomarkers/urine , Databases, Factual , Humans , Malnutrition/complications , Metabolic Diseases/metabolism , Metabolic Diseases/therapy , Non-Randomized Controlled Trials as Topic , Nutritional Status , Pancreas/surgery , Pancreatic Neoplasms/metabolism , Pancreatic Neoplasms/therapy , Quality of Life , Randomized Controlled Trials as Topic
18.
J Surg Res ; 198(2): 311-6, 2015 Oct.
Article En | MEDLINE | ID: mdl-25918005

BACKGROUND: Disparities in colon cancer survival have been reported to result from advanced stage at diagnosis and delayed therapy. We hypothesized that delays in treatment among medically underserved patients occur as a result of system-level barriers in a safety-net hospital system. MATERIALS AND METHODS: Retrospective review and analysis of colon cancer patients treated in a large safety-net hospital system between May 2008 and May 2012. Data were collected on demographics, stage at diagnosis, time to surgery, time to adjuvant chemotherapy, and vital status. Regression analyses were performed to determine predictors of delays and failure to receive therapy. RESULTS: Of 248 patients treated for colon cancer, 56% (n = 140) had advanced disease at the time of presentation; furthermore, 29.1% of all colectomies for colon cancer were performed on an urgent or emergent basis. Thirty-six patients with stage III and IV disease did not receive chemotherapy (26%). Race, age, gender, and hospice care did not predict receipt of chemotherapy or delays to treatment. Patients with stage I colon cancer had a significantly longer interval between diagnosis and elective surgery when compared with patients with stage II, III, and IV colon cancer, with only 10% (n = 3) undergoing resection sooner than 6 wk after diagnosis. CONCLUSIONS: One in three patients diagnosed with colon cancer in a large safety-net hospital system require urgent or emergent surgery, and one in two present with advanced disease. Reducing disparities should focus on earlier diagnosis of colon cancer and improving access to surgical specialists.


Adenocarcinoma/therapy , Colonic Neoplasms/therapy , Safety-net Providers/statistics & numerical data , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Time Factors
19.
Pancreas ; 44(4): 522-7, 2015 May.
Article En | MEDLINE | ID: mdl-25872128

OBJECTIVES: Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States. The incidence of pancreatic cancer in African Americans is 50% to 90% higher than the incidence in other racial groups. African Americans also have the worst prognosis. This is an evidence-based review of pancreatic cancer in African Americans with particular emphasis on baseline characteristics, treatment, and survival. METHODS: We queried PubMed in search for articles describing racial disparities in pancreatic cancer. Two categories of terms were "anded" together: pancreatic cancer terms and race terms. The last search was performed on November 14, 2013. RESULTS: We summarized the data on pancreatic cancer baseline characteristics, treatment, and survival for African Americans that we obtained from the following databases: (1) Surveillance, Epidemiology, and End Results, 1988-2008; (2) California Cancer Registry 1988-1998; (3) Cancer Survivor Program of Orange County/San Diego Imperial Organization for Cancer Control, 1988-1998; and (4) Harris County, 1998-2010. CONCLUSIONS: Overall, pancreatic cancer survival of African Americans has not significantly improved over the past several decades despite advances in multimodality therapy; African Americans continue to face worse outcomes than whites. Although baseline characteristics, treatment, and biological factors offer some explanation, they do not completely explain the disparities in incidence and survival.


Adenocarcinoma/ethnology , Black or African American , Health Status Disparities , Healthcare Disparities/ethnology , Pancreatic Neoplasms/ethnology , Adenocarcinoma/diagnosis , Adenocarcinoma/mortality , Adenocarcinoma/therapy , Combined Modality Therapy , Humans , Incidence , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/therapy , Risk Factors , United States/epidemiology
20.
Ann Surg ; 259(4): 605-12, 2014 Apr.
Article En | MEDLINE | ID: mdl-24374513

OBJECTIVE: To test by randomized prospective multicenter trial the hypothesis that pancreaticoduodenectomy (PD) without the use of intraperitoneal drainage does not increase the frequency or severity of complications. BACKGROUND: Some surgeons have abandoned the use of drains placed during pancreas resection. METHODS: We randomized 137 patients to PD with (n = 68, drain group) and without (n = 69, no-drain group) the use of intraperitoneal drainage and compared the safety of this approach and spectrum of complications between the 2 groups. RESULTS: There were no differences between drain and no-drain cohorts in demographics, comorbidities, pathology, pancreatic duct size, pancreas texture, baseline quality of life, or operative technique. PD without intraperitoneal drainage was associated with an increase in the number of complications per patient [1 (0-2) vs 2 (1-4), P = 0.029]; an increase in the number of patients who had at least 1 ≥grade 2 complication [35 (52%) vs 47 (68%), P = 0.047]; and a higher average complication severity [2 (0-2) vs 2 (1-3), P = 0.027]. PD without intraperitoneal drainage was associated with a higher incidence of gastroparesis, intra-abdominal fluid collection, intra-abdominal abscess (10% vs 25%, P = 0.027), severe (≥grade 2) diarrhea, need for a postoperative percutaneous drain, and a prolonged length of stay. The Data Safety Monitoring Board stopped the study early because of an increase in mortality from 3% to 12% in the patients undergoing PD without intraperitoneal drainage. CONCLUSIONS: This study provides level 1 data, suggesting that elimination of intraperitoneal drainage in all cases of PD increases the frequency and severity of complications.


Drainage/methods , Pancreaticoduodenectomy , Postoperative Care/methods , Postoperative Complications/prevention & control , Adult , Aged , Early Termination of Clinical Trials , Female , Follow-Up Studies , Humans , Incidence , Length of Stay , Male , Middle Aged , Pancreatic Fistula/epidemiology , Pancreatic Fistula/etiology , Pancreatic Fistula/prevention & control , Pancreaticoduodenectomy/mortality , Postoperative Care/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Prospective Studies , Severity of Illness Index , Treatment Outcome
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