Surgical versus non-surgical management for patients with malignant bowel obstruction (S1316): a pragmatic comparative effectiveness trial.

BACKGROUND: Malignant small bowel obstruction has a poor prognosis and is associated with multiple related symptoms. The optimal treatment approach is often unclear. We aimed to compare surgical versus non-surgical management with the aim to determine the optimal approach for managing malignant bowel obstruction. METHODS: S1316 was a pragmatic comparative effectiveness trial done within the National Cancer Trials Network at 30 hospital and cancer research centres in the USA, Mexico, Peru, and Colombia. Participants had an intra-abdominal or retroperitoneal primary cancer confirmed via pathological report and malignant bowel disease; were aged 18 years or older with a Zubrod performance status 0-2 within 1 week before admission; had a surgical indication; and treatment equipoise. Participants were randomly assigned (1:1) to surgical or non-surgical treatment using a dynamic balancing algorithm, balancing on primary tumour type. Patients who declined consent for random assignment were offered a prospective observational patient choice pathway. The primary outcome was the number of days alive and out of the hospital (good days) at 91 days. Analyses were based on intention-to-treat linear, logistic, and Cox regression models combining data from both pathways and adjusting for potential confounders. Treatment complications were assessed in all analysed patients in the study. This completed study is registered with ClinicalTrials.gov, NCT02270450. FINDINGS: From May 11, 2015, to April 27, 2020, 221 patients were enrolled (143 [65%] were female and 78 [35%] were male). There were 199 evaluable participants: 49 in the randomised pathway (24 surgery and 25 non-surgery) and 150 in the patient choice pathway (58 surgery and 92 non-surgery). No difference was seen between surgery and non-surgery for the primary outcome of good days: mean 42·6 days (SD 32·2) in the randomised surgery group, 43·9 days (29·5) in the randomised non-surgery group, 54·8 days (27·0) in the patient choice surgery group, and 52·7 days (30·7) in the patient choice non-surgery group (adjusted mean difference 2·9 additional good days in surgical versus non-surgical treatment [95% CI -5·5 to 11·3]; p=0·50). During their initial hospital stay, six participants died, five due to cancer progression (four patients from the randomised pathway, two in each treatment group, and one from the patient choice pathway, in the surgery group) and one due to malignant bowel obstruction treatment complications (patient choice pathway, non-surgery). The most common grade 3-4 malignant bowel obstruction treatment complication was anaemia (three [6%] patients in the randomised pathway, all in the surgical group, and five [3%] patients in the patient choice pathway, four in the surgical group and one in the non-surgical group). INTERPRETATION: In our study, whether patients received a surgical or non-surgical treatment approach did not influence good days during the first 91 days after registration. These findings should inform treatment decisions for patients hospitalised with malignant bowel obstruction. FUNDING: Agency for Healthcare Research and Quality and the National Cancer Institute. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

One hundred human pancreatic islet isolations at Baylor Research Institute.

The effectiveness of pancreatic islet isolation must be maximized to make islet cell transplantation (ICT) a standard therapy. We have performed 100 human islet isolations at Baylor Research Institute including islet isolations for research, for clinical allogeneic transplantation, and for autologous islet transplantation. In this study, we analyzed the results of these isolations. First, we assessed 79 islet isolations using brain-dead donors to determine variables associated with successful islet isolation. Univariate logistic regression analysis revealed that seven variables influenced the success of islet isolation for allogeneic ICT: cause of death, mechanism of death, techniques for pancreas procurement and preservation, heavy fatty infiltration, collagenase type, dilution time, and islet purification method. Multivariate regression analysis revealed that only the current isolation protocol, the Baylor Islet Isolation Method (BIIM)-with its four required elements of pancreas procurement by the team, pancreatic ductal injection, the two-layer method with perfluorocarbon, and density-adjusted density gradient purification-had a significant positive impact on successful islet isolation (P = 0.02). Second, we compared allogeneic and autologous ICT using the BIIM. There were no significant differences in islet yields between allogeneic and autologous ICT using the BIIM; total islet yield after purification was 628 ± 84 × 10(3) IE in allogeneic ICT vs. 576 ± 49 × 10(3) IE in autologous ICT (P = 0.59). This retrospective study revealed that the BIIM provided favorable outcomes for both autologous and allogeneic ICT.

Variables associated with islet yield in autologous islet cell transplantation for chronic pancreatitis.

The goal of total pancreatectomy followed by autologous islet cell transplantation is to manage pain and prevent surgical diabetes for patients with severe chronic pancreatitis. We performed this procedure in 17 patients from November 2006 to October 2009 at Baylor University Medical Center. All patients were included in this retrospective study and were divided into two groups based on islet yield in the final product based on patient body weight: a low-yield group (<5000 IE/kg) and a high-yield group (>/=5000 IE/kg). There were significant differences between the two groups in the rate of pancreatic findings on computed tomography (low vs high group, 88% vs 22%: P = 0.02), Cambridge classification score for endoscopic retrograde cholangiopancreatography (3.8 +/- 0.2 vs 2.1 +/- 0.6: P = 0.03), number of positive endoscopic ultrasonography criteria (6.0 +/- 0.8 vs 3.5 +/- 0.4: P = 0.04), and distension score (1.9 +/- 0.4 vs 3.7 +/- 0.2: P = 0.006). A significant reduction in narcotics use after the operation was observed in both groups (P = 0.03 and P = 0.009 in the low and high groups, respectively, using a paired t test). Excellent graft function and glycemic control after the transplantation were also demonstrated in both groups. Patients in the high-yield group were in the early stage of chronic pancreatitis, which led to excellent pancreatic distention for islet isolation; however, the excellent clinical outcomes were observed in both low- and high-yield groups.

Clinical utility of breast magnetic resonance imaging in patients presenting with primary breast cancer.

Since magnetic resonance imaging (MRI) of the breast has been shown to be sensitive in identifying the extent of the primary tumor and other foci of cancer, we examined its clinical utility in the surgical management of breast cancer patients. From January 2004 to April 2007, 117 patients with newly diagnosed breast cancer underwent bilateral MRI prior to definitive surgical management. Additional lesions were found in 27 patients (23.1%) in the ipsilateral breast and 19 patients (16.2%) in the contralateral breast. Twelve patients (10.3%) had more than one new lesion identified. Six patients (5.1%) had a larger area of tumor than detected by mammography or ultrasound. Additional biopsies were performed in 27 patients (23.1%). Additional foci of cancer were identified in 17 patients (14.5%): 12 (10.2%) in the ipsilateral breast and 5 (4.3%) in the contralateral breast. This information changed the clinical management in 23 cases (19.7%). Further studies are needed to confirm the benefits of MRI relative to its costs and to further identify the appropriate patients to undergo this imaging procedure.

Management of ampullary lesions.

Adenomatous lesions of the ampulla of Vater are relatively rare neoplasms that raise many questions regarding standard management. Adenocarcinoma often will be found in ampullary lesions and should be treated by pancreaticoduodenectomy (PD). Benign-appearing adenomas may be treated by PD, transduodenal ampullectomy (AMP), or endoscopic ampullectomy (EA). AMP and EA have decreased morbidity and mortality compared with PD but are limited by concerns for appropriate resection margins, high recurrence rates, and the need for surveillance endoscopy or additional procedures. Preoperative endoscopic biopsies should be obtained to identify carcinoma, but they have high false-negative rates and cannot be relied upon to rule out malignancy. Intraoperative frozen section evaluation should be requested routinely during AMP, with conversion to PD if carcinoma is demonstrated. The gold standard management of benign adenomas has not been clarified, but the goal for all treatment modalities is complete resection. Patients with familial adenomatous polyposis may be exceptions to this, and routine surveillance endoscopy and biopsy with selective resection have been advocated by some as an alternative to complete resection. Adjuvant chemoradiation has a very limited role in the treatment of ampullary carcinoma and ideally should be offered in the setting of a clinical trial. Metastatic and locally advanced, unresectable lesions may be palliated by surgical or endoscopic bypass, as well as by celiac plexus blockade.

The utility of capsule endoscopy and its role for diagnosing pathology in the gastrointestinal tract.

BACKGROUND: Capsule endoscopy (CE) is a new device that enables visualization of areas of the small bowel that were previously inaccessible through other noninvasive procedures. The purpose of this study is to evaluate this new diagnostic tool and its efficacy in finding occult GI tract pathology. METHODS: A single-institution retrospective review was completed on patients undergoing CE from January 2002 to September 2004. Data evaluated included indications for CE, results of previous studies, CE findings, and complications of the CE study. RESULTS: A total of 702 CE studies in 652 patients were performed during the study period. Suspicious GI bleeding presenting as anemia, guaiac positive stools, or history of gross bleeding were the most common reasons to perform CE (75.8%). Other indications included abdominal pain (11.5%), diarrhea (3.1%), or others (9.5%). In studies performed for GI bleeding (N = 532), a source was found in 49.3% of CE studies. Arteriovenous malformation (AVM) was the most common reported finding (43.9%), followed by ulcer (24.1%), colon or gastric pathology (14.1%), mass/tumor (9.1%), and stricture (6.9%). Patients with abdominal pain (n = 81) had findings 46.9% of the time including edema/ulcer (47.4%), stricture (10.5%), mass/tumor (26.3%), gastric pathology (10.5%), AVM (2.6%), or sprue (2.6%). Patients with diarrhea (n = 22) had findings 45.5% of the time including edema/ulcer (75%), mass/tumor (12.5%), or sprue (12.5%). A total of 66 patients underwent operative exploration after a CE study at this institution either because of the observed findings or for other reasons. There were 12 (1.7%) CE studies in which the capsule was retained and required surgical removal. Pathology at the retention site included benign strictures or adhesions (n = 9, 75%), Crohn's stricture (n = 1, 8.3%) carcinoid tumor (n = 1, 8.3%), and villous adenoma (n = 1, 8.3%). CONCLUSIONS: CE is an accurate study to locate abnormalities in the GI tract that may have either been missed by previous diagnostic studies or cannot be observed through other non-invasive means. When used for diagnostic challenges such as GI bleeding with no apparent source, CE can be helpful in guiding surgical decisions in patients and thus should be integrated as part of the diagnostic workup.

Usefulness of endoscopic ultrasound in patients at high risk of choledocholithiasis.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) has been considered the nonsurgical gold standard for the diagnosis and treatment of choledocholithiasis (CDL). Complications include a 0.1% to 1.3% mortality rate and a 5% to 19% morbidity rate, including a reported 1.8% to 6.7% incidence of postprocedure pancreatitis. Twenty-seven percent to 67% of ERCPs done for suspected choledocholithiasis ultimately have negative results. Endoscopic ultrasound (EUS) has been proposed as an alternate means of diagnosing choledocholithiasis that may eliminate the need for ERCP and its associated morbidities in certain patients. METHODS: Retrospective chart review identified 30 patients who underwent EUS with or without ERCP for suspected choledocholithiasis. Reports of all procedures performed were obtained and data were collected on all biliary abnormalities identified on both EUS and ERCP. RESULTS: Pancreaticobiliary abnormalities were identified in 27 of 30 patients (90%) at EUS. Most common diagnoses included CDL (n = 9, 30%), biliary sludge (n = 11, 37%), pancreatitis (n = 8, 27%), and cholelithiasis (n = 7, 23%). Subsequent ERCP was performed in 14 patients (47%). Indications included a diagnosis of CDL by EUS (n = 9) and abnormal liver function tests (n = 5). CDL was identified in 5 of 14 patients (36%), and microlithiasis/biliary sludge was identified in an additional 5 patients (36%). In 4 patients, CDL was identified by EUS but not by ERCP. ERCP did not identify any new cases of CDL after EUS: of 21 patients without evidence of CDL on EUS, none were subsequently shown to have CDL or to develop any complications related to common duct stones. CONCLUSIONS: EUS is an effective method of diagnosing CDL. It demonstrates both a high sensitivity and specificity for identifying common bile duct stones. Its use as a screening modality in patients suspected of having CDL may allow more selective use of ERCP.

Validation study of intraoperative fine-needle aspiration of parathyroid tissue with measurement of parathyroid hormone levels using the rapid intraoperative assay.

BACKGROUND: Surgical treatment of hyperparathyroidism relies on the ability to accurately identify parathyroid tissue. The use of intraoperative fine-needle aspiration (FNA) with measurement of intact parathyroid hormone level (iPTH-FNA) has been suggested as a useful adjunct and is evaluated in this pilot study. METHODS: An institutional review board-approved retrospective review was performed on patients undergoing parathyroid exploration for primary hyperparathyroidism who also underwent selective FNA at the end of the procedure. FNA was performed on excised parathyroid tissue, ipsilateral thyroid tissue, and muscle. RESULTS: Ten patients underwent FNA. Mean iPTH-FNA values were 1559.6 pg/mL (range, 675-1775) for parathyroid, 51.4 pg/mL(range, 10-248) for thyroid, and 34.1 pg/mL (range, 14-128) for muscle. All iPTH-FNA assay results were significantly higher for parathyroid tissue than for either thyroid tissue (P < 0.05) or muscle (P < 0.05). There were no significant iPTH-FNA assay differences between thyroid and muscle (P = 0.09). CONCLUSIONS: Intraoperative FNA of parathyroid tissue with the rapid iPTH assay can correctly identify parathyroid tissue. It may prove to be a useful surgical adjunct in the treatment of hyperparathyroidism.

Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is an effective treatment of severe obesity and one of the fastest growing surgical procedures in the United States. METHODS: A single institution prospective database of patients undergoing outpatient laparoscopic (lap) RYGB over a 3-year period was reviewed. Study end points included hospital discharge within 23 hours, 30-day hospital readmission rate, early (<30 day) and late complication rates, and 30-day perioperative mortality. Variables assessed included surgeon experience, patient demographics, comorbidities, operative time, Roux limb pathway, intraoperative steroid bolus, and use of dexmedetomidine. RESULTS: Two thousand consecutive patients undergoing outpatient lap RYGB were identified, and 84% (n = 1669) were discharged within 23 hours. Of these, 1.7% (n = 34) were readmitted within 30 days. The overall early and late complication rates were 1.9% (n = 38) and 4.3% (n = 86), respectively. The 30-day mortality rate was 0.1% (n = 2), and neither patient was discharged before death. Univariate analysis demonstrated surgeon experience (<50 cases), age (<56 years), body mass index (<60 kg/m), weight (400 lbs), comorbidities (<5), and intraoperative steroid bolus as predictive of successful outpatient discharge. Multivariate analysis revealed surgeon experience, comorbidities, body mass index, and steroid bolus as predictive variables. CONCLUSIONS: These data suggest that outpatient lap RYGB can be performed with acceptable perioperative complication rates, hospital readmission, and mortality rates. Surgeon experience, careful patient selection, and the use of intraoperative steroid bolus predicted optimal patient outcomes.

A prospective randomized trial demonstrating valved implantable ports have fewer complications and lower overall cost than nonvalved implantable ports.

BACKGROUND: The purpose of the current study was to evaluate whether a totally implanted valved subcutaneous port system would have fewer complications as compared to a standard nonvalved port. METHODS: Study subjects requiring port placement were randomized to receive a valved port (PASV; Boston Scientific, Natick, MA) or a nonvalved port (BardPort; Bard Accesss Systems, Salt Lake City, UT). Each port was placed with standard operative technique. Difficulty with blood return, excess time spent accessing the port, and required interventions were reported over the initial 180 days of port usage. RESULTS: Seventy-three patients were randomized to receive either a valved port (n = 37) or a nonvalved port (n = 36). No major complications were identified from port placement, and there were no differences in rates of infection between the 2 ports. A reported inability to withdraw blood was noted in the valved port group on 21 of 364 (5.8%) port accessions and in the nonvalved port group on 37 of 341 (11%) accessions (P = 0.02). Significantly more total time was spent ensuring adequate blood draw from nonvalved ports as opposed to valved ports (750 minutes vs. 1545 minutes, respectively) (P <0.03). CONCLUSIONS: This study revealed that the PASV valved port is associated with significantly fewer instances of poor blood return and less nursing access time, indicating that a port with a PASV valve may be superior to a nonvalved device.

The role of pelvic exenteration in the management of recurrent rectal cancer.

BACKGROUND: Use of extirpative surgery in the setting of recurrent rectal cancer is controversial given the poor overall outcome of such patients and the morbidity associated with exenteration. METHODS: A retrospective review of patients treated for recurrent rectal cancer from 1990 to 2002 was performed. RESULTS: Twenty-two patients underwent pelvic exenteration. Seventeen underwent potentially curative resection, 5 were for palliation only. There was 1 operative death. Fifteen suffered at least 1 complication; 9 suffered multiple complications. Ten patients required readmission to the hospital. The overall disease-free interval was 11 months. Potentially curative and palliative resections resulted in median survivals of 20.4 and 8.4 months, respectively (P = 0.049). CONCLUSIONS: While patients may derive oncologic and palliative benefits from exenteration, the price in terms of operative morbidity remains high. Newer measures of operative morbidity are necessary to better appraise the value of this radical approach to recurrent rectal cancer.

A randomized trial of valved vs nonvalved implantable ports for vascular access.

BACKGROUND: Vascular access devices placed into the central venous system are used routinely in the medical management of many patients. Catheter tip occlusion is a common complication of open-ended catheters, causing difficulty with blood withdrawal and infusion. This study evaluated whether a valved subcutaneous port system would have fewer associated complications than a standard nonvalved port. METHODS: Study subjects requiring port placement were randomized to receive a PASV (valved) port or a nonvalved BardPort. Standard technique was used to place both types of ports. Patients were monitored for 180 days after implantation, and data on major complications were collected. Difficulty with blood return and excess time spent accessing the port were studied as indicators of catheter tip occlusion. This study is an interim analysis of an ongoing prospective study, with an anticipated accrual of 100 patients. RESULTS: Fifty-four patients were randomized to receive either the PASV port (n = 27) or a BardPort (n = 27). All patients required venous access for treatment of malignancy. No major complications were identified from port placement. No patient had major sepsis due to infected catheters. Overall complications included catheter leakage in 1 patient (3.7%, BardPort) and venous thrombosis in 1 patient in each group (3.7% per group). Difficulty in blood draw was noted in the PASV group on 16 of 273 (5.9%) port accessions and in the BardPort group on 30 of 266 (11.3%) accessions (P = 0.04). Thrombolytic agents were required in 14 (5.1%) port accessions in the PASV group and 21 (7.9%) port accessions in the BardPort group (P = 0.25). Significantly more total time was spent ensuring adequate blood draw from BardPorts as opposed to PASV ports (870 vs 435 minutes, respectively) (P = 0.01). CONCLUSION: This initial analysis reveals that the valved PASV port system is associated with significantly fewer instances of poor blood return and thus decreases the time required for nurses to obtain blood return before infusion.

Closure of proximal colorectal fistulas using fibrin sealant.

Fibrin glue has been used in upper gastrointestinal and perianal fistula disease, but its success in proximal colorectal pathology has not been widely documented. This report describes the use of endoscopically injected fibrin glue as a successful adjunct to traditional methods in accelerating the closure of colorectal fistulas. A retrospective review was performed on cases of colon and rectal fistulas treated with fibrin glue using an endoscopic technique of injection. Fistulas were injected via a flexible fiberoptic endoscope with fluoroscopic guidance (three) or directly with a rigid proctoscope (one). Fibrin glue was mixed directly from cryoprecipitate, thrombin, and calcium (one) or using a Tisseel kit (three) (Baxter, Deerfield, IL). Four patients were identified and included: two J-pouch fistulas, a colocutaneous fistula, and a complex rectocutaneous fistula. The median duration of fistula was 33 days (range 4-365 days). Total parenteral nutrition and bowel rest were used in two patients and three required drainage of an abscess. All fistulas were obliterated and patients required a mean of one application of fibrin glue (range one to two). The mean time to resuming a regular diet postinjection was 2 days (range 1-5). No complications were identified. Fistula resolution was documented in all cases with a contrast enema and no patient has had a fistula recurrence at a median follow-up of 12 months (range 6-65). This preliminary series demonstrates that fibrin glue can be used to obliterate proximal rectal, colonic, and pouch fistulas. Endoscopy and fluoroscopy may aid in administering the fibrin glue. This adjunctive technique may shorten the time to fistula closure and may allow some patients to avoid further surgery.

Systematic postoperative radiologic follow-up in patients with non-small cell lung cancer for detecting second primary lung cancer in stage IA.

HYPOTHESIS: Systematic postoperative evaluation of patients with non-small cell lung cancer will identify treatable second primary lung cancer and local recurrences. DESIGN: Retrospective review from January 1, 1996, to December 31, 2000. The follow-up protocol included an annual computed tomographic examination of the chest with interval chest radiography every 4 months for 2 years and every 6 months for 3 additional years. SETTING: A National Cancer Institute-designated comprehensive cancer center. PATIENTS: One hundred twenty-four patients with resected non-small cell lung cancer. MAIN OUTCOME MEASURES: Number and size of second primary and locally recurrent tumors, secondary surgical procedures, and survival of patients who underwent resection. RESULTS: The median diameter of resected second primary tumors detected by computed tomography was 14 mm (range, 8-28 mm) and by chest radiography was 26.5 mm (range, 23.0-35.0 mm) (P<.001). Of 14 patients with second primary lung cancer treated surgically, 9 were without evidence of disease at a median of 20 months (range, 4-56 months), 2 were alive with disease at 13 and 37 months, 2 died of unrelated causes but without evidence of disease at 7 and 35 months, and 1 died intraoperatively of a cardiac arrhythmia. CONCLUSIONS: Systematic follow-up of non-small cell lung cancer, including annual computed tomography, detects second primary lung cancer in stage IA. Limited pulmonary resections are often feasible in these patients. Locally recurrent lung cancer is infrequently resectable.

Management of carotid body paragangliomas and review of a 30-year experience.

Carotid body tumors are rare neoplasms and must be considered in the evaluation of all lateral neck masses; early surgical removal has been recommended. In this study, the medical records of 29 patients with 34 carotid body paragangliomas who were treated at our institution between 1971 and 2001 were retrospectively reviewed. An overview is provided of this lesion, including diagnosis, classification, metastatic potential, possible secretory function, operative techniques, and nonsurgical methods of management. Carotid body tumors may be familial and are more often bilateral in these instances; five patients (17%) had bilateral tumors in this series. The criterion for malignancy is demonstrated by metastatic tumor in lymph nodes or distant organs. Three patients (10%) had malignant tumors, one with hepatic metastases. One patient (3%) in our series exhibited abnormal serotonin production. Vascular reconstruction was necessary in eight cases (28%). No stroke occurred, however, two arterial thromboses (7%), five permanent cranial nerve deficits (17%), and one death (3%) from massive pulmonary embolism were seen. Our experience demonstrates that early operative management is warranted to avoid the possibility of eventual metastasis and progressive local invasion to the point of inoperability.

Giant adrenal myelolipoma.

Myelolipoma of the adrenal gland is a benign tumor comprising adipose cells and mature hematopoietic elements. Most of these lesions are small and asymptomatic. Giant myelolipomas weighing greater than 4 kg are quite rare with three other cases reported in the literature. A case is presented of a giant myelolipoma that was resected surgically. The literature is reviewed regarding this topic with emphasis on diagnostic and therapeutic implications.