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1.
Gastrointest Endosc ; 89(6): 1160-1168.e9, 2019 06.
Article in English | MEDLINE | ID: mdl-30738985

ABSTRACT

BACKGROUND AND AIMS: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. METHODS: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees. RESULTS: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases. CONCLUSION: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.).


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Clinical Competence , Education, Medical, Graduate/standards , Endoscopy, Digestive System/education , Endosonography , Fellowships and Scholarships/standards , Gastroenterology/education , Learning Curve , Endoscopic Ultrasound-Guided Fine Needle Aspiration , Humans , Prospective Studies , Sphincterotomy, Endoscopic/education
2.
Gastroenterology ; 155(5): 1483-1494.e7, 2018 11.
Article in English | MEDLINE | ID: mdl-30056094

ABSTRACT

BACKGROUND & AIMS: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence. METHODS: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs. RESULTS: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate). CONCLUSIONS: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Clinical Competence , Endosonography , Cholangiopancreatography, Endoscopic Retrograde/standards , Endosonography/standards , Humans , Learning Curve , Prospective Studies , Quality Indicators, Health Care
3.
J Palliat Med ; 21(9): 1339-1343, 2018 09.
Article in English | MEDLINE | ID: mdl-29905501

ABSTRACT

Patients diagnosed with advanced stages of gastrointestinal (GI) malignancies are often quite symptomatic, with symptoms primarily related to anatomic sites of obstruction. Endoscopic approaches to the palliation of GI malignancies have begun to overtake surgical approaches as first line in interventional management. We brought together a team of interventional gastroenterologists and palliative care experts to collate practical pearls for the types of endoscopic interventions used for symptom management in patients with GI malignancies. In this article, we use a "Top 10" format to highlight issues that may help palliative care physicians recognize common presentations of advanced GI malignancies, address interventional approaches to improve symptom burden, and improve the quality of shared decision making and goals-of-care discussions.


Subject(s)
Gastrointestinal Neoplasms/therapy , Palliative Care , Symptom Flare Up , Humans , Quality of Life
5.
Endosc Int Open ; 4(12): E1313-E1318, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27995195

ABSTRACT

Background and study aims: It is common practice to perform ampullectomy without endoscopic ultrasound (EUS) for ampullary lesions < 1 cm but no data exists to support it. No studies have explored whether EUS findings of invasion correlate with malignancy or high-grade dysplasia (HGD) on pathology. We explored the association between adenoma size, pathology results, and invasion on EUS.  Patients and methods: This was a single-center retrospective cohort study at a large tertiary care academic hospital. Chart review was performed for 161 patients with benign ampullary lesions on endoscopic biopsy (identified by pathology records). The primary outcomes were mean size (mm) of adenomas and pathology findings with and without intraductal and/or duodenal wall invasion on EUS.  Results: Invasion was identified by EUS in 41 (34.1 %) of 120 patients who underwent EUS. The mean size of the lesion in these patients was 20.9 mm (±â€Š11.6 mm) compared to 13.9 mm (±â€Š11.3 mm, P = 0.0001) in patients without invasion. A receiver operating characteristic (ROC) curve (AUC 0.73, 95 % CI 0.63 - 0.83) revealed 100 % sensitivity for absence of invasion on EUS in lesions less than 6.5 mm. Invasion on EUS had sensitivity of 63.0 % (95 % CI 47.0 % - 77.0 %) and specificity 88.0 % (95 % CI 78.0 % - 95.0 %) for presence of malignancy, HGD or invasion on pathology. Conclusions: EUS should be considered for ampullary lesions > 6.5 mm. This study provides evidence to support the practice of ampullectomy without EUS for smaller adenomas. EUS evidence of invasion is highly specific for pathologic malignancy, HGD, or invasion (which preclude endoscopic ampullectomy).

6.
World J Gastrointest Endosc ; 7(3): 278-82, 2015 Mar 16.
Article in English | MEDLINE | ID: mdl-25789100

ABSTRACT

AIM: To evaluate the success rates of performing therapy utilizing a rotational assisted enteroscopy device in endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy patients. METHODS: Between June 1, 2009 and November 8, 2012, we performed 42 ERCPs with the use of rotational enteroscopy for patients with altered anatomy (39 with gastric bypass Roux-en-Y, 2 with Billroth II gastrectomy, and 1 with hepaticojejunostomy associated with liver transplant). The indications for ERCP were: choledocholithiasis: 13 of 42 (30.9%), biliary obstruction suggested on imaging: 20 of 42 (47.6%), suspected sphincter of Oddi dysfunction: 4 of 42 (9.5%), abnormal liver enzymes: 1 of 42 (2.4%), ascending cholangitis: 2 of 42 (4.8%), and bile leak: 2 of 42 (4.8%). All procedures were completed with the Olympus SIF-Q180 enteroscope and the Endo-Ease Discovery SB overtube produced by Spirus Medical. RESULTS: Successful visualization of the major ampulla was accomplished in 32 of 42 procedures (76.2%). Cannulation of the bile duct was successful in 26 of 32 procedures reaching the major ampulla (81.3%). Successful therapeutic intervention was completed in 24 of 26 procedures in which the bile duct was cannulated (92.3%). The overall intention to treat success rate was 64.3%. In terms of cannulation success, the intention to treat success rate was 61.5%. Ten out of forty two patients (23.8%) required admission to the hospital after procedure for abdominal pain and nausea, and 3 of those 10 patients (7.1%) had a diagnosis of post-ERCP pancreatitis. The average hospital stay was 3 d. CONCLUSION: It is reasonable to consider an attempt at rotational assisted ERCP prior to a surgical intervention to alleviate biliary complications in patients with altered surgical anatomy.

7.
Gastroenterol Res Pract ; 2013: 642428, 2013.
Article in English | MEDLINE | ID: mdl-23606835

ABSTRACT

Background and Study Aims. Endoscopic placement of self-expanding metal stents (SEMSs) is indicated for palliation of inoperable malignant biliary obstruction. A fully covered biliary SEMS (WallFlex Biliary RX Boston Scientific, Natick, USA) was assessed for palliation of extrahepatic malignant biliary obstruction. Patients and Methods. 58 patients were included in this prospective, multicenter series conducted under an FDA-approved IDE. Main outcome measurements included (1) absence of stent occlusion within six months or until death, whichever occurred first and (2) technical success, need for reintervention, bilirubin levels, stent patency, time to stent occlusion, and adverse events. Results. Technical success was achieved in 98% (57/58), with demonstrated acute removability in two patients. Adequate clinical palliation until completion of followup was achievedin 98% (54/55) of evaluable patients, with 1 reintervention due to stent obstruction after 142 days. Mean total bilirubin decreased from 8.9 mg/dL to 1.2 mg/dL at 1 month. Device-related adverse events were limited and included 2 cases of cholecystitis. One stent migrated following radiation therapy. Conclusions. The WallFlex Biliary fully covered stent yielded technically successful placement with uncomplicated acute removal where required, appropriate reduction in bilirubin levels, and low rates of stent migration and occlusion. This SEMS allows successful palliation of malignant extrahepatic biliary obstruction.

8.
Ann Surg ; 257(2): 315-22, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23059497

ABSTRACT

OBJECTIVE: The objective of this study was to compare the effectiveness, morbidity, and mortality associated with endoscopic ampullectomy (EA) and surgical ampullectomy (SA). BACKGROUND: The proposed management of benign ampullary lesions includes local resection (EA or SA) and en bloc resection (pancreaticoduodenectomy). Most agree that en bloc resection entails a significant morbidity and mortality. No study has previously compared EA and SA for the treatment of benign ampullary lesions. METHODS: Medical records of patients selected for ampullectomy at Duke University Medical Center from 1991 to 2010 were reviewed. RESULTS: After review, 109 patients were confirmed to have undergone ampullectomy for a suspected benign ampullary lesion. Sixty-eight patients underwent EA, whereas 41 patients underwent SA. Patients in each group were identical in terms of age, sex, race, and comorbid conditions, except that EA had a higher rate of severe obesity (body mass index >35). Endoscopic ampullectomy was found to have a significantly reduced length of stay, lower morbidity, and readmission rates, but it had similar rates of mortality, margin-positive excisions, and reinterventions. CONCLUSIONS: In patients selected for ampullectomy for benign ampullary lesions, EA was found to have equivalent efficacy when compared with SA. Moreover, EA had lower morbidity and identical mortality. These findings suggest that patients would likely benefit from an aggressive endoscopic approach before consideration for surgery.


Subject(s)
Algorithms , Ampulla of Vater , Biliary Tract Surgical Procedures/methods , Common Bile Duct Neoplasms/surgery , Endoscopy , Adult , Aged , Female , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome
9.
JOP ; 13(5): 514-8, 2012 Sep 10.
Article in English | MEDLINE | ID: mdl-22964958

ABSTRACT

CONTEXT: Animal studies have demonstrated a role for substance P binding to neurokinin-1 receptor in the pathogenesis of acute pancreatitis. OBJECTIVE: Our aim was to assess the efficacy of a neurokinin-1 receptor antagonist (aprepitant) at preventing post-ERCP pancreatitis in high risk patients. DESIGN: Randomized, double-blind, placebo controlled trial at a single academic medical center. INTERVENTION: Patients at high risk for post-ERCP pancreatitis received either placebo or oral aprepitant administered 4 hours prior to ERCP, 80 mg 24 hours after the first dose, and then 80 mg 24 hours after the second dose. PATIENTS: Thirty-four patients received aprepitant and 39 patients received placebo. STATISTICS: Fisher's exact test was used to compare incidence of post-ERCP pancreatitis in the two groups. RESULTS: Baseline characteristics were similar between the two groups. Incidence of acute pancreatitis was 7 in the aprepitant group and 7 in the placebo group. Hospitalization within 7 days post-procedure for abdominal pain that did not meet criteria for acute pancreatitis occurred in 6 and 9 patients in the aprepitant and placebo groups respectively (P=0.772). CONCLUSIONS: Aprepitant did not lower incidence of post-ERCP pancreatitis in this preliminary human study. Larger studies potentially using the recently available intravenous formulation are necessary to conclusively clarify the efficacy of aprepitant in this setting.  


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Morpholines/therapeutic use , Pancreatitis/prevention & control , Administration, Oral , Adult , Antiemetics/administration & dosage , Antiemetics/therapeutic use , Aprepitant , Double-Blind Method , Humans , Male , Middle Aged , Morpholines/administration & dosage , Pancreatitis/etiology , Pilot Projects , Risk Factors , Time Factors , Treatment Outcome
10.
Gastroenterology Res ; 5(2): 57-62, 2012 Apr.
Article in English | MEDLINE | ID: mdl-27785181

ABSTRACT

BACKGROUND: Stent related occlusion and migration remains a problem despite attempts to improve stent design over this time period. Flanged polyethylene plastic stents (FPS) remains the stent of choice in most centers. Early failure of stents placed for malignant extrahepatic biliary strictures (MEBS) has not previously been studied in detail. We set out to determine the incidence and reasons for biliary stent change within 30 days of the index procedure in a large tertiary center population during a period where (FPS) was the sole plastic stent used. METHODS: Retrospective analysis of endoscopic retrograde cholangiography (ERCP) was undertaken in patients who were stented for presumed or known MEBS between 1993 and 2001. Patients who required repeat stenting within 30 days were identified. RESULTS: All 508 patients were stented for MEBS. 5.7% of patients had a total of 34 repeat stenting procedures within 30 days of the index procedure; 27of 29 index stents were plastic, 2 were self-expandable metal stents (SEMS), 20 (3.9%) patients had stent failure as the reason for a stent exchange (plastic stent occlusion n = 15, mean time to stent change 14 ± 8.3 days; metal stent occlusion n = 2, mean time to stent change 24.5 ± 7.8 days; plastic stent migration n = 3, mean time to stent change 25 ± 5.3 days). There was a statistically significant difference in the time to stent change between the occluded plastic stent and migrated plastic stent cases (P = 0.045, 95% CI -21.7 to -0.29). 6 patients spent at least 2 additional days in hospital as a result of stent failure. CONCLUSIONS: Early stent failure is an uncommon problem, especially in patients with SEMS. Early plastic stent failure appears to occur sooner with stent occlusion than with stent migration. Early stent failure is associated with significant morbidity and bears an economic impact in additional procedures and hospital stay.

11.
Pancreas ; 40(4): 533-9, 2011 May.
Article in English | MEDLINE | ID: mdl-21499206

ABSTRACT

OBJECTIVES: This study aimed to evaluate whether synthetic secretin is effective in reducing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. METHODS: This is a single academic medical center, prospective, randomized, double-blind, placebo-controlled trial using secretin (dose of 16 µg) administered intravenously immediately before ERCP. Patients were evaluated for the primary outcome of post-ERCP pancreatitis as diagnosed by a single investigator. RESULTS: A total of 1100 patients were screened, of whom 869 were randomly assigned to receive secretin (n = 426) or placebo (n = 443) before ERCP and were evaluated after the procedure for efficacy of secretin. The incidence of pancreatitis in the secretin group compared with the placebo group was 36 (8.7%) of 413 patients versus 65 (15.1%) of 431 patients, respectively, P = 0.004. In the subgroup analysis, secretin was highly protective against post-ERCP pancreatitis for patients undergoing biliary sphincterotomy (6/129 vs 32/142, P < 0.001), patients undergoing cannulation of the common bile duct (26/339 vs 56/342, P < 0.001), and patients not undergoing pancreatic sphincterotomy (26/388 vs 57/403, P = 0.001). Analysis of the interaction between these groups reveals that the primary effect of secretin prophylaxis was prevention of post-ERCP pancreatitis in patients undergoing biliary sphincterotomy. CONCLUSIONS: Synthetic secretin reduces the risk of post-ERCP pancreatitis, particularly in patients in undergoing biliary sphincterotomy.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde/methods , Pancreatitis/prevention & control , Postoperative Complications/prevention & control , Secretin/therapeutic use , Adult , Aged , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Double-Blind Method , Female , Gastrointestinal Agents/administration & dosage , Gastrointestinal Agents/therapeutic use , Humans , Injections, Intravenous , Male , Middle Aged , Pancreatitis/etiology , Postoperative Complications/etiology , Prospective Studies , Secretin/administration & dosage , Treatment Outcome
12.
JOP ; 10(1): 37-42, 2009 Jan 08.
Article in English | MEDLINE | ID: mdl-19129613

ABSTRACT

CONTEXT: The role of EUS to evaluate subtle radiographic abnormalities of the pancreas is not well defined. OBJECTIVE: To assess the yield of EUS+/-FNA for focal or diffuse pancreatic enlargement/fullness seen on abdominal CT scan in the absence of discrete mass lesions. DESIGN: Retrospective database review. SETTING: Tertiary referral center. PATIENTS AND INTERVENTIONS: Six hundred and 91 pancreatic EUS exams were reviewed. Sixty-nine met inclusion criteria of having been performed for focal enlargement or fullness of the pancreas. Known chronic pancreatitis, pancreatic calcifications, acute pancreatitis, discrete mass on imaging, pancreatic duct dilation (greater than 4 mm) and obstructive jaundice were excluded. MAIN OUTCOME MEASUREMENT: Rate of malignancy found by EUS+/-FNA. RESULTS: FNA was performed in 19/69 (27.5%) with 4 new diagnoses of pancreatic adenocarcinoma, one metastatic renal cell carcinoma, one metastatic colon cancer, one chronic pancreatitis and 12 benign results. Eight patients had discrete mass lesions on EUS; two were cystic. All malignant diagnoses had a discrete solid mass on EUS. CONCLUSIONS: Pancreatic enlargement/fullness is often a benign finding related to anatomic variation, but was related to malignancy in 8.7% of our patients (6/69). EUS should be strongly considered as the next step in the evaluation of patients with focal enlargement of the pancreas when clinical suspicion of malignancy exists.


Subject(s)
Carcinoma/diagnosis , Pancreas/diagnostic imaging , Pancreas/pathology , Pancreatic Neoplasms/diagnosis , Tomography, X-Ray Computed/methods , Adult , Aged , Aged, 80 and over , Biopsy, Fine-Needle , Endosonography/methods , Female , Humans , Male , Middle Aged , Retrospective Studies , Ultrasonography, Interventional/methods
13.
Surg Endosc ; 23(9): 1933-7, 2009 Sep.
Article in English | MEDLINE | ID: mdl-19116743

ABSTRACT

BACKGROUND: There is debate about whether intraoperative cholangiography (IOC) should be performed routinely or selectively during laparoscopic cholecystectomy (LC) in patients with suspected choledocholithiasis. The timing of endoscopic retrograde cholangiopancreatography (ERCP) in these patients also is an issue. We reviewed the experience in our center, where a management algorithm limiting ERCP in relation to LC was adopted. METHODS: We retrospectively reviewed every LC performed by one surgeon during 6 years and the related ERCPs. RESULTS: A total of 264 LCs were performed. In 30 patients, stones were cleared or excluded by preoperative ERCP. In the remaining 234 LCs, 31 of 34 IOCs were successfully performed. Two of 31 IOCs were positive for bile duct stones; stone removal was successful in each patient at subsequent ERCP. Only 10 of 201 patients who did not have IOC required postsurgical ERCP within 10 weeks of LC, 3 of whom had common bile duct stones at ERCP. CONCLUSIONS: For patients who underwent LC, we performed selective IOC with postoperative ERCP for positive studies. Review of our experience using this algorithm showed it to be a powerful tool in limiting unnecessary ERCPs. Our data suggest that routine preoperative ERCP cannot be justified. Selective IOC during LC misses relatively few cases of biliary stones; these can be managed quickly by experienced endoscopists.


Subject(s)
Cholangiography , Cholangiopancreatography, Endoscopic Retrograde , Cholecystectomy, Laparoscopic , Choledocholithiasis/diagnostic imaging , Radiography, Interventional , Unnecessary Procedures , Algorithms , Case Management , Cholangiography/statistics & numerical data , Cholangiopancreatography, Endoscopic Retrograde/statistics & numerical data , Cholecystitis/surgery , Choledocholithiasis/epidemiology , Cholelithiasis/surgery , Diagnostic Tests, Routine , Female , Humans , Intraoperative Care , Male , Postoperative Care , Radiography, Interventional/statistics & numerical data , Retrospective Studies , Risk
14.
Gastrointest Endosc ; 66(3): 475-82, 2007 Sep.
Article in English | MEDLINE | ID: mdl-17725937

ABSTRACT

BACKGROUND: EUS plays an important role in the preoperative staging of esophageal cancer. Recent data have called into question the staging accuracy of EUS, particularly in patients with early disease. OBJECTIVE: Our goals were to assess our institution's EUS staging accuracy by experienced endosonographers in a contemporary cohort of patients encompassing a wide range of disease stages and to assess staging accuracy after dilation of malignant strictures. DESIGN: Retrospective data review. SETTING: Single tertiary care center. PATIENTS AND INTERVENTIONS: A total of 42 patients with esophageal cancer undergoing preoperative EUS staging without neoadjuvant chemoradiotherapy between December 1999 and December 2004 were evaluated. MAIN OUTCOME MEASUREMENTS: EUS T and N stage sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. RESULTS: EUS accurately predicted T stage in 76% of cases and N stage in 89% of cases. Staging accuracy for T3 versus T1 and T2 disease and for N0 versus N1 disease was not significantly different. In 11 cases, malignant strictures required dilation, with 6 tumors being passable post dilation. Post dilation, T staging accuracy was 80% in impassable tumors and 100% in passable tumors, and N staging accuracy was 100% in the passable tumors. LIMITATIONS: Relatively small number of patients. CONCLUSIONS: EUS accurately predicts T and N stage in patients with a range of disease stages. EUS provides good staging accuracy after dilation of malignant strictures regardless of whether full tumor traversal post dilation is possible.


Subject(s)
Adenocarcinoma/pathology , Carcinoma, Neuroendocrine/pathology , Carcinoma, Squamous Cell/pathology , Endosonography , Esophageal Neoplasms/pathology , Adenocarcinoma/diagnostic imaging , Adenocarcinoma/surgery , Biopsy , Carcinoma, Neuroendocrine/diagnostic imaging , Carcinoma, Neuroendocrine/surgery , Carcinoma, Squamous Cell/diagnostic imaging , Carcinoma, Squamous Cell/surgery , Cohort Studies , Esophageal Neoplasms/diagnostic imaging , Esophageal Neoplasms/surgery , Esophagectomy , Esophagus/pathology , Female , Humans , Lymphatic Metastasis/pathology , Male , Neoplasm Invasiveness/pathology , Neoplasm Staging , Retrospective Studies , Sensitivity and Specificity
15.
Chest ; 131(2): 539-48, 2007 Feb.
Article in English | MEDLINE | ID: mdl-17296659

ABSTRACT

BACKGROUND: Endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) is a minimally invasive alternative technique for mediastinal staging of non-small cell lung cancer. A metaanalysis was performed to estimate the diagnostic accuracy of EUS-FNA for staging mediastinal lymph nodes (N2/N3 disease) in patients with lung cancer. METHODS: Relevant studies were identified using Medline (1966 to November 2005), CINAHL, and citation indexing. Included studies used histology or adequate clinical follow-up (> 6 months) as the "gold standard," and provided sufficient data for calculating sensitivity and specificity. Summary receiver operating characteristic curves metaanalysis was performed to estimate the pooled sensitivity and specificity. RESULTS: In 18 eligible studies, EUS-FNA identified 83% of patients (95% confidence interval [CI], 78 to 87%) with positive mediastinal lymph nodes (pooled sensitivity) and 97% of patients (95% CI, 96 to 98%) with negative mediastinal lymph nodes (pooled specificity). In eight studies that were limited to patients who had abnormal mediastinal lymph nodes seen on CT scans, the sensitivity was 90% (95% CI, 84 to 94%) and the specificity was 97% (95% CI, 95 to 98%). In patients without abnormal mediastinal lymph nodes seen on CT scans (four studies), the pooled sensitivity was 58% (95% CI, 39 to 75%). Minor complications were reported in 10 cases (0.8%). There were no major complications. CONCLUSIONS: EUS-FNA is a safe modality for the invasive staging of lung cancer that is highly sensitive when used to confirm metastasis to mediastinal lymph nodes seen on CT scans. In addition, among lung cancer patients with normal mediastinal adenopathy seen on CT scans, despite lower sensitivity, it has the potential to prevent unnecessary surgery in a large proportion of cases missed by CT scanning.


Subject(s)
Biopsy, Fine-Needle , Carcinoma, Non-Small-Cell Lung/pathology , Endosonography , Lung Neoplasms/pathology , Neoplasm Staging/methods , Surgery, Computer-Assisted , Carcinoma, Non-Small-Cell Lung/diagnostic imaging , Humans , Lung Neoplasms/diagnostic imaging , ROC Curve
16.
Gastrointest Endosc ; 63(7): 966-75, 2006 Jun.
Article in English | MEDLINE | ID: mdl-16733111

ABSTRACT

BACKGROUND: Diagnosing pancreatic cancer by EUS-FNA is a potentially appealing alternative to percutaneous biopsy. AIM: To compare EUS-FNA with CT or US-guided FNA for diagnosing pancreatic cancer. DESIGN: Single center, prospective, randomized, cross-over. SETTING: Duke University Medical Center. POPULATION: Eighty-four patients referred with suspicious solid pancreatic mass lesions randomized to CT/US-FNA (n = 43) or EUS-FNA (n = 41). INTERVENTION: Patients underwent an imaging procedure/FNA. If cytology was nondiagnostic, cross over to the other modality was offered. Final outcome was determined by clinical follow-up every 6 months for 2 years and/or surgical pathology for patients with negative FNA. MAIN OUTCOME MEASUREMENTS: Sensitivity and accuracy of EUS-FNA versus CT/US-FNA for pancreatic cancer. RESULTS: There were 16 true positive (TP) by CT/US-FNA and 21 TP by EUS-FNA. Sixteen of the 20 CT/US-FNA negative patients crossed over to EUS-FNA; 12 underwent FNA, 4 had no mass at EUS. Seven of the 12 had positive EUS-FNA. Eight EUS-FNA negative crossed over to CT/US; 4 had no mass at CT/US, 3 remained true negative throughout follow-up, 1 had chronic pancreatitis at surgery. The sensitivity of CT/US-FNA and EUS-FNA for detecting malignancy was 62% and 84%, respectively. A comparison of the accuracy for CT/US-FNA and EUS-FNA was not statistically significant (P = .074, chi(2)). LIMITATIONS: Failure to meet target enrollment resulted in an inability to demonstrate a statistically significant difference between the 2 modalities. CONCLUSIONS: EUS-FNA is numerically (though not quite statistically) superior to CT/US-FNA for the diagnosis of pancreatic malignancy.


Subject(s)
Adenocarcinoma/pathology , Biopsy, Fine-Needle/methods , Endosonography , Pancreatic Neoplasms/pathology , Tomography, X-Ray Computed , Adenocarcinoma/diagnostic imaging , Aged , Algorithms , Cross-Over Studies , Endoscopy, Gastrointestinal/methods , Female , Humans , Male , Middle Aged , Pancreatic Neoplasms/diagnostic imaging , Prospective Studies , Sensitivity and Specificity
17.
Am J Gastroenterol ; 100(11): 2395-402, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16279891

ABSTRACT

OBJECTIVES: We hypothesized that early intervention in patients with lower gastrointestinal bleeding (LGIB) would improve outcomes and therefore conducted a prospective randomized study comparing urgent colonoscopy to standard care. METHODS: Consecutive patients presenting with LGIB without upper or anorectal bleeding sources were randomized to urgent purge preparation followed immediately by colonoscopy or a standard care algorithm based on angiographic intervention and expectant colonoscopy. RESULTS: A total of 50 patients were randomized to each group. A definite source of bleeding was found more often in urgent colonoscopy patients (diverticula, 13; angioectasia, 4; colitis, 4) than in the standard care group (diverticula, 8; colitis, 3) (the odds ratio for the difference among the groups was 2.6; 95% CI 1.1-6.2). In the urgent colonoscopy group, 17 patients received endoscopic therapy; in the standard care group, 10 patients had angiographic hemostasis. There was no difference in outcomes among the two groups-including: mortality 2%versus 4%, hospital stay 5.8 versus 6.6 days, ICU stay 1.8 versus 2.4 days, transfusion requirements 4.2 versus 5 units, early rebleeding 22%versus 30%, surgery 14%versus 12%, or late rebleeding 16%versus 14% (mean follow-up of 62 and 58 months). CONCLUSION: Although urgent colonoscopy identified a definite source of LGIB more often than a standard care algorithm based on angiography and expectant colonoscopy, the approaches are not significantly different with regard to important outcomes. Thus, decisions concerning care for patients with acute LGIB should be based on individual experience and local expertise.


Subject(s)
Colonic Diseases/diagnosis , Colonoscopy , Gastrointestinal Hemorrhage/diagnosis , Aged , Angiography , Blood Transfusion , Cathartics/administration & dosage , Colitis, Ischemic/diagnosis , Colitis, Ischemic/therapy , Colonic Diseases/diagnostic imaging , Colonic Diseases/therapy , Critical Care , Diverticulum, Colon/diagnosis , Diverticulum, Colon/therapy , Emergencies , Female , Follow-Up Studies , Gastrointestinal Hemorrhage/diagnostic imaging , Gastrointestinal Hemorrhage/therapy , Hemostatic Techniques , Hospitalization , Humans , Intestinal Mucosa/diagnostic imaging , Intestinal Mucosa/pathology , Length of Stay , Male , Prospective Studies , Recurrence , Telangiectasis/diagnosis , Telangiectasis/therapy , Treatment Outcome
18.
Gastrointest Endosc ; 61(7): 804-8, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15933679

ABSTRACT

BACKGROUND: The utility of EGD when used as an initial test for the evaluation of dysphagia is unclear. The objective was to determine the yield and the predictive factors of significant pathology when EGD is performed as the initial test to evaluate dysphagia. METHODS: This is a retrospective analysis of a computerized database. Data on patients who underwent EGD for dysphagia were retrieved from the endoscopy database of 6 endoscopy units. Patients who had undergone prior esophageal evaluation, failed EGD, or who had a history of prior upper-GI pathology were excluded. Univariate and multivariable logistic regression analyses were performed to evaluate any relation between endoscopic findings and presenting clinical features. RESULTS: A total of 1649 patients with dysphagia (mean age 56.7 years, standard deviation 16.4; M:F 3:2) were analyzed. Abnormal findings at EGD were found in 70% (1150) of the patients, and a major pathology was seen in 54% (898). Male gender (p=0.0001), heartburn (p=0.0007), and odynophagia (p=0.0001) predicted the presence of major pathology. Cancer was found in 4% (70) of patients and was predicted by male gender (p=0.0002), age (p=0.01), and weight loss (p=0.04). The esophagus was normal in 29% (483) of patients and was predicted by female gender (p=0.0001) and the absence of heartburn (p=0.0004) but not age. There was a lack of details on patients' presentation and clinical history and an absence of long-term clinical follow-up. CONCLUSIONS: EGD is an effective and an appropriate tool for the initial evaluation of patients presenting with dysphagia. Early EGD should be considered, particularly, in male patients aged more than 40 years old who concomitantly report heartburn, odynophagia, or weight loss.


Subject(s)
Deglutition Disorders/diagnosis , Endoscopy, Digestive System , Esophageal Diseases/diagnosis , Abdominal Pain/diagnosis , Adult , Age Factors , Cohort Studies , Esophageal Neoplasms/diagnosis , Esophageal Stenosis/diagnosis , Esophagitis/diagnosis , Female , Heartburn/diagnosis , Humans , Male , Middle Aged , Predictive Value of Tests , Retrospective Studies , Sex Factors , Weight Loss
19.
Gastrointest Endosc ; 61(7): 854-61, 2005 Jun.
Article in English | MEDLINE | ID: mdl-15933687

ABSTRACT

BACKGROUND: Image-guided FNA is a popular method for evaluating pancreatic lesions, but few large studies on pancreatic FNA exist. METHODS: Cytologic material, imaging reports, and clinical follow-up information were reviewed from pancreatic FNA cases performed over a 5-year period. RESULTS: A total of 1050 pancreatic FNAs were obtained by EUS (n = 843), US (n = 140), and CT (n = 67). On-site assessment was performed in 89.2% (n = 937) of cases. Findings were as follows: positive for neoplasm 48.9% (n = 503), negative 29.1% (n = 306), descriptive 10% (n = 105), suspicious 5.9% (n = 62), atypical/inconclusive 4.6% (n = 48), and nondiagnostic/inadequate 1.5% (n = 26). Follow-up in the form of histology or at least 6 months of clinical observation was available for 61.2% (n = 643). There was an overall false-positive rate of 0.3% and a false-negative rate of 14.3%. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy were as follows: 79.4, 99.0, 99.4, 67.9, 84.5 for the total series, respectively; 79.9, 98.8, 99.2, 72.5, 86.5 for EUS, respectively; 77.9, 100, 100, 48.6, 81.7 for US, respectively; and 78.6, 100, 100, 47.1, 82.0 for CT, respectively. In general, accuracy was not influenced by lesion size or site, number of FNA passes, or number of procedures per patient. After controlling for lesion size, EUS resulted in greater accuracy than US or CT when evaluating lesions <3 cm ( p = 0.015). CONCLUSIONS: All imaging modalities showed moderate to high sensitivity, specificity, and accuracy. Logistic regression analysis showed that for lesions <3 cm, the EUS method had higher accuracy than US or CT. No statistically significant difference was seen for larger lesions or for the number of FNA passes.


Subject(s)
Biopsy, Fine-Needle/methods , Diagnostic Imaging , Pancreatic Neoplasms/pathology , Adenocarcinoma/pathology , Adolescent , Adult , Aged , Aged, 80 and over , Biopsy, Fine-Needle/statistics & numerical data , Carcinoma/pathology , Endosonography/statistics & numerical data , False Negative Reactions , False Positive Reactions , Follow-Up Studies , Humans , Lymphoma/pathology , Middle Aged , Neuroendocrine Tumors/pathology , Pancreatic Neoplasms/secondary , Pancreatic Pseudocyst/pathology , Predictive Value of Tests , Retrospective Studies , Sensitivity and Specificity , Tomography, X-Ray Computed/statistics & numerical data , Ultrasonography, Interventional/statistics & numerical data
20.
Ann Surg Oncol ; 12(3): 214-21, 2005 Mar.
Article in English | MEDLINE | ID: mdl-15827813

ABSTRACT

BACKGROUND: Neoadjuvant (preoperative) chemoradiotherapy (CRT) for pancreatic cancer offers theoretical advantages over the standard approach of surgery followed by adjuvant CRT. We hypothesized that histological responses to CRT would be significant prognostic factors in patients undergoing neoadjuvant CRT followed by resection. METHODS: Since 1994, 193 patients with biopsy-proven pancreatic adenocarcinoma have completed neoadjuvant CRT, and 70 patients have undergone resection. Specimens were retrospectively examined by an individual pathologist for histological responses (tumor necrosis, tumor fibrosis, and residual tumor load) and immunohistochemical staining for p53 and epidermal growth factor receptor. Factors influencing overall survival were analyzed with the Kaplan-Meier (univariate) and Cox proportional hazards (multivariate) methods. RESULTS: The estimated overall survival (median +/- SE) in the entire group of patients undergoing resection was 23 +/- 4.2 months, with an estimated 3-year survival of 37% +/- 6.6% and a median follow-up of 28 months. Complete histological responses occurred in 6% of patients. Overexpression of p53 was more common in patients with large residual tumor loads. Tumor necrosis was an independent negative prognostic factor, as were positive lymph nodes, a large residual tumor load, and poor tumor differentiation. CONCLUSIONS: Histological response to neoadjuvant CRT--as measured by residual tumor load--may be useful as a surrogate marker for treatment efficacy. Characterization of the tumor cells that survive neoadjuvant CRT may help us to identify new or more appropriate targets for systemic therapy.


Subject(s)
Adenocarcinoma/drug therapy , Adenocarcinoma/radiotherapy , Neoadjuvant Therapy , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/radiotherapy , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Aged , Analysis of Variance , Antineoplastic Agents/therapeutic use , Chemotherapy, Adjuvant , Female , Humans , Male , Middle Aged , Neoplasm Staging , Pancreatic Neoplasms/pathology , Pancreatic Neoplasms/surgery , Prognosis , Proportional Hazards Models , Radiotherapy, Adjuvant , Retrospective Studies , Risk Factors , Survival Analysis , Treatment Outcome
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