Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial.

BACKGROUND & AIMS: Thermal treatment of the defect margin after endoscopic mucosal resection (EMR) of large nonpedunculated colorectal lesions reduces the recurrence rate. Both snare tip soft coagulation (STSC) and argon plasma coagulation (APC) have been used for thermal margin treatment, but there are few data directly comparing STSC with APC for this indication. METHODS: We performed a randomized 3-arm trial in 9 US centers comparing STSC with APC with no margin treatment (control) of defects after EMR of colorectal nonpedunculated lesions ≥15 mm. The primary end point was the presence of residual lesion at first follow-up. RESULTS: There were 384 patients and 414 lesions randomized, and 308 patients (80.2%) with 328 lesions completed ≥1 follow-up. The proportion of lesions with residual polyp at first follow-up was 4.6% with STSC, 9.3% with APC, and 21.4% with control subjects (no margin treatment). The odds of residual polyp at first follow-up were lower for STSC and APC when compared with control subjects (P = .001 and P = .01, respectively). The difference in odds was not significant between STSC and APC. STSC took less time to apply than APC (median, 3.35 vs 4.08 minutes; P = .019). Adverse event rates were low, with no difference between arms. CONCLUSIONS: In a randomized trial STSC and APC were each superior to no thermal margin treatment after EMR. STSC was faster to apply than APC. Because STSC also results in lower cost and plastic waste than APC (APC requires an additional device), our study supports STSC as the preferred thermal margin treatment after colorectal EMR. (Clinicaltrials.gov, Number NCT03654209.).

Factors associated with complete clip closure after endoscopic mucosal resection of large colorectal polyps.

BACKGROUND AND STUDY AIM : Delayed bleeding is a common adverse event following endoscopic mucosal resection (EMR) of large colorectal polyps. Prophylactic clip closure of the mucosal defect after EMR of nonpedunculated polyps larger than 20 mm reduces the incidence of severe delayed bleeding, especially in proximal polyps. This study aimed to evaluate factors associated with complete prophylactic clip closure of the mucosal defect after EMR of large polyps. METHODS : This is a post hoc analysis of the CLIP study (NCT01936948). All patients randomized to the clip group were included. Main outcome was complete clip closure of the mucosal resection defect. The defect was considered completely closed when no remaining mucosal defect was visible and clips were less than 1 cm apart. Factors associated with complete closure were evaluated in multivariable analysis. RESULTS : In total, 458 patients (age 65, 58 % men) with 494 large polyps were included. Complete clip closure of the resection defect was achieved for 338 polyps (68.4 %); closure was not complete for 156 (31.6 %). Factors associated with complete closure in adjusted analysis were smaller polyp size (odds ratio 1.06 for every millimeter decrease [95 % confidence interval 1.02-1.08]), good access (OR 3.58 [1.94-9.59]), complete submucosal lifting (OR 2.28 [1.36-3.90]), en bloc resection (OR 5.75 [1.48-22.39]), and serrated histology (OR 2.74 [1.35-5.56]). CONCLUSIONS : Complete clip closure was not achieved for almost one in three resected large nonpedunculated polyps. While stable access and en bloc resection facilitate clip closure, most factors associated with clip closure are not modifiable. This highlights the need for alternative closure options and measures to prevent bleeding.

Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial.

BACKGROUND & AIMS: There is debate over the type of electrosurgical setting that should be used for polyp resection. Some endoscopists use a type of blended current (yellow), whereas others prefer coagulation (blue). We performed a single-blinded, randomized trial to determine whether type of electrosurgical setting affects risk of adverse events or recurrence. METHODS: Patients undergoing endoscopic mucosal resection of nonpedunculated colorectal polyps 20 mm or larger (n = 928) were randomly assigned, in a 2 × 2 design, to groups that received clip closure or no clip closure of the resection defect (primary intervention) and then to either a blended current (Endocut Q) or coagulation current (forced coagulation) (Erbe Inc) (secondary intervention and focus of the study). The study was performed at multiple centers, from April 2013 through October 2017. Patients were evaluated 30 days after the procedure (n = 919), and 675 patients underwent a surveillance colonoscopy at a median of 6 months after the procedure. The primary outcome was any severe adverse event in a per patient analysis. Secondary outcomes were complete resection and recurrence at first surveillance colonoscopy in a per polyp analysis. RESULTS: Serious adverse events occurred in 7.2% of patients in the Endocut group and 7.9% of patients in the forced coagulation group, with no significant differences in the occurrence of types of events. There were no significant differences between groups in proportions of polyps that were completely removed (96% in the Endocut group vs 95% in the forced coagulation group) or the proportion of polyps found to have recurred at surveillance colonoscopy (17% and 17%, respectively). Procedural characteristics were comparable, except that 17% of patients in the Endocut group had immediate bleeding that required an intervention, compared with 11% in the forced coagulation group (P = .006). CONCLUSIONS: In a randomized trial to compare 2 commonly used electrosurgical settings for the resection of large colorectal polyps (Endocut vs forced coagulation), we found no difference in risk of serious adverse events, complete resection rate, or polyp recurrence. Electrosurgical settings can therefore be selected based on endoscopist expertise and preference. Clinicaltrials.gov ID NCT01936948.

Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial.

BACKGROUND & AIMS: Bleeding is the most common severe complication after endoscopic mucosal resection of large colon polyps and is associated with significant morbidity and cost. We examined whether prophylactic closure of the mucosal defect with hemoclips after polyp resection reduces the risk of bleeding. METHODS: We performed a multicenter, randomized trial of patients with a large nonpedunculated colon polyp (≥20 mm) at 18 medical centers in North America and Spain from April 2013 through October 2017. Patients were randomly assigned to groups that underwent endoscopic closure with a clip (clip group) or no closure (control group) and followed. The primary outcome, postprocedure bleeding, was defined as a severe bleeding event that required hospitalization, a blood transfusion, colonoscopy, surgery, or another invasive intervention within 30 days after completion of the colonoscopy. Subgroup analyses included postprocedure bleeding with polyp location, polyp size, or use of periprocedural antithrombotic medications. We also examined the risk of any serious adverse event. RESULTS: A total of 919 patients were randomly assigned to groups and completed follow-up. Postprocedure bleeding occurred in 3.5% of patients in the clip group and 7.1% in the control group (absolute risk difference [ARD] 3.6%; 95% confidence interval [CI] 0.7%-6.5%). Among 615 patients (66.9%) with a proximal large polyp, the risk of bleeding in the clip group was 3.3% and in the control group was 9.6% (ARD 6.3%; 95% CI 2.5%-10.1%); among patients with a distal large polyp, the risks were 4.0% in the clip group and 1.4% in the control group (ARD -2.6%; 95% CI -6.3% to -1.1%). The effect of clip closure was independent of antithrombotic medications or polyp size. Serious adverse events occurred in 4.8% of patients in the clip group and 9.5% of patients in the control group (ARD 4.6%; 95% CI 1.3%-8.0%). CONCLUSIONS: In a randomized trial, we found that endoscopic clip closure of the mucosal defect following resection of large colon polyps reduces risk of postprocedure bleeding. The protective effect appeared to be restricted to large polyps located in the proximal colon. ClinicalTrials.gov no: NCT01936948.

Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial.

BACKGROUND: The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary drainage (PTBD) to endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction (MHO). METHODS: The INTERCPT trial is a multi-center, comparative effectiveness, randomized, superiority trial of PTBD vs. ERC for decompression of suspected MHO. One hundred and eighty-four eligible patients across medical centers in the United States, who provide informed consent, will be randomly assigned in 1:1 fashion via a web-based electronic randomization system to either ERC or PTBD as the initial drainage and, if indicated, diagnostic procedure. All subsequent clinical interventions, including crossover to the alternative procedure, will be dictated by treating physicians per usual clinical care. Enrolled subjects will be assessed for successful biliary drainage (primary outcome measure), adequate tissue diagnosis, adverse events, the need for additional procedures, hospitalizations, and oncological outcomes over a 6-month follow-up period. Subjects, treating clinicians and outcome assessors will not be blinded. DISCUSSION: The INTERCPT trial is designed to determine whether PTBD or ERC is the better initial approach when managing a patient with suspected MHO, a common clinical dilemma that has never been investigated in a randomized trial. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.

Laparoscopic-assisted versus open pancreaticoduodenectomy: early favorable physical quality-of-life measures.

BACKGROUND: We compared outcomes and postpancreatectomy quality of life (QOL) in paired cohorts of patients undergoing conventional open pancreaticoduodenectomy (OPD) or laparoscopic-assisted pancreaticoduodenectomy (LAPD). METHODS: Comparative analysis of QOL was performed in a matched cohort of 53 patients after OPD or LAPD between 2010 and 2013. The Medical Outcomes Study Short Form-36 Health Survey and the Karnofsky score were used. RESULTS: Physical component score, mental component score, and Karnofsky scores were calculated at multiple time points for OPD (n = 25) and LAPD (n = 28). Operative times, complications, and readmission rates were equivalent. Time to starting adjuvant therapy trended toward clinical importance in LAPD (61 vs 110 days, P = .0878). Duration of stay was less in LAPD (7.10 vs 9.44 days, P = .02). LAPD had a superior QOL centered on functional status compared with OPD (physical component score 49.09 vs 38.4, P = .04; Karnofsky 92.22 vs 66.92%, P = .003). These statistical differences were not observed beyond 6 months. CONCLUSION: LAPD provided a more favorable QOL within the first 6 months and shorter length of stay compared with conventional OPD. LAPD may serve as an alternative operative therapy to potentially minimize delays in receipt of and enhance tolerability of adjuvant therapies.

Evaluation of occult gastrointestinal bleeding.

Occult gastrointestinal bleeding is defined as gastrointestinal bleeding that is not visible to the patient or physician, resulting in either a positive fecal occult blood test, or iron deficiency anemia with or without a positive fecal occult blood test. A stepwise evaluation will identify the cause of bleeding in the majority of patients. Esophagogastroduodenoscopy (EGD) and colonoscopy will find the bleeding source in 48 to 71 percent of patients. In patients with recurrent bleeding, repeat EGD and colonoscopy may find missed lesions in 35 percent of those who had negative initial findings. If a cause is not found after EGD and colonoscopy have been performed, capsule endoscopy has a diagnostic yield of 61 to 74 percent. Deep enteroscopy reaches into the mid and distal small bowel to further investigate and treat lesions found during capsule endoscopy or computed tomographic enterography. Evaluation of a patient who has a positive fecal occult blood test without iron deficiency anemia should begin with colonoscopy; asymptomatic patients whose colonoscopic findings are negative do not require further study unless anemia develops. All men and postmenopausal women with iron deficiency anemia, and premenopausal women who have iron deficiency anemia that cannot be explained by heavy menses, should be evaluated for occult gastrointestinal bleeding. Physicians should not attribute a positive fecal occult blood test to low-dose aspirin or anticoagulant medications without further evaluation.

Cholangiocarcinoma treatment.

Cholangiocarcinoma (CCA) is a tumor of the bile ducts that usually presents with biliary obstruction and has a poor prognosis. The treatment of CCA is challenging as the tumor is usually diagnosed late and the treatments are not very effective except when complete surgical resection is possible. In carefully selected patients, liver transplant can be a curative therapy. In the majority of cases, complete surgical resection is not possible and palliation is the mainstay of treatment. Stenting, using plastic or metallic stents, allows for biliary drainage. Photodynamic therapy plays a role in palliation and might play a role in adjuvant or neoadjuvant therapy. While radiation and chemotherapy can be beneficial, newer ablative techniques and targeted chemotherapies are promising.

A prospective study of prophylactic long-acting octreotide in high-risk patients undergoing pancreaticoduodenectomy.

BACKGROUND: Postoperative pancreatic fistula (postoperative pancreatic fistula [POPF]) is the most common complication after pancreaticoduodenectomy. Despite some studies showing little effect of octreotide in unselected patients, we hypothesized that in high-risk patients depot octreotide may reduce the risk of POPF. METHODS: Sixty-eight patients were prospectively evaluated for inclusion in the current study. Two groups were identified: pancreatic ducts ≤3 mm (high risk) and those with ducts >3 mm (low risk). Thirty-two patients were low risk, whereas 36 patients were high risk. High-risk patients were treated preoperatively with depot octreotide and begun on an intravenous drip for 24 hours. Low-risk patients underwent pancreaticoduodenectomy without pharmacologic intervention. In contrast, the control cohort represents 106 retrospectively analyzed patients who underwent a pancreaticoduodenectomy without depot octreotide injection without regard to low- or high-risk status. RESULTS: Overall, POPF was 11 of 68 (16%). Nine of 36 high risk patients treated with depot octreotide developed POPF (25%), and 2 of 32 low risk patients developed POPF (6%). In the control cohort of high-risk patients, 9 of 44 (20%) and 3 of 62 (5%) low-risk patients developed POPF (P = .628 when comparing the development of POPF in high-risk patients with or without pharmacologic intervention). CONCLUSIONS: Prophylactic use of depot octreotide in high-risk patients does not result in reduced incidence of POPF. Duct size has a significant impact on the occurrence of POPF.

Cholangiocarcinoma: epidemiology, risk factors, pathogenesis, and diagnosis.

Cholangiocarcinoma (CCA) is a rare tumor arising from the epithelium of the intrahepatic or the extrahepatic bile ducts. It is rarely diagnosed before 40 years of age except in patients with primary sclerosing cholangitis. CCA is usually clinically silent until the tumor obstructs the bile ducts. Carbohydrate antigen 19-9 is the most commonly used tumor marker, and magnetic resonance cholangiopancreatography is the best available imaging modality for CCA. Endoscopic retrograde cholangiopancreatography and cholangioscopy allow tissue acquisition. Positron emission tomography may play a role in identifying occult metastases. Tissue diagnosis is obtained by brush cytology or bile duct biopsy.

Large colorectal polyps: endoscopic management and rate of malignancy: does size matter?

BACKGROUND AND STUDY AIMS: High rate of malignancy has been reported in large colorectal polyps. However, studies were limited by including surgically resected polypoid lesions, only polyp ≥3 cm, only sessile polyps or carcinoma in situ. The aim of the study was to define the prevalence of invasive carcinoma among colorectal polyps ≥2 cm in diameter detected by colonoscopy and also to study the success of endoscopic resection. PATIENTS AND METHODS: All polypectomies of ≥2 cm colorectal polyps were identified from our endoscopy and pathology database and patients' medical records were reviewed for gross features, techniques of resection, complications, histology, and follow-up. Standard statistical tests were applied for calculating the rates, prevalence, and difference in proportions. RESULTS: Colonoscopic resection of 183 large polyps was performed in 174 patients over a period of 6 years (55% men and 45% women), mean age 64 years (median 67 y and range 25-91 y). The majority of polyps were sessile (84%). Fifty-six percent were located in the right colon. Invasive cancer was found in 10% of polyps. Endoscopic resection was successful in 89% of patients. Postpolypectomy bleeding and perforation was noted in 5% and 2% of patients, respectively. No death was observed. Seventy-eight percent of patients completed >1 year of follow-up after initial polypectomy. Recurrence of adenoma was noted in 12%, which was managed successfully by colonoscopic polypectomy techniques. CONCLUSIONS: The rate of invasive cancer is low among endoscopically resected large colorectal polyps and most of these polyps can be resected successfully via colonoscopy with minimal morbidity and no mortality. A close endoscopic follow-up is required to monitor for recurrence.

Nonampullary duodenal polyps: characteristics and endoscopic management.

BACKGROUND: Guidelines for endoscopic resection and surveillance of nonampullary duodenal (NAD) polyps are still not well-defined. OBJECTIVE: To describe the characteristics of NAD polyps and evaluate the role of endoscopic management. DESIGN: Retrospective review. SETTING: Tertiary-care academic center. PATIENTS: This study involved 59 patients with NAD polyps. INTERVENTION: Endoscopic polypectomy, biopsy, and argon plasma coagulation. MAIN OUTCOME MEASUREMENTS: Complete polypectomy, complications, and recurrence. RESULTS: Ninety-six endoscopies were performed. The mean patient age was 62.8 years. The mean (+/- standard deviation) polyp size was 17.2 mm +/- 1.6 mm. The mean follow-up time was 26 months. Most lesions were sessile, solitary, and located in the descending duodenum. The procedure most often performed was submucosal injection followed by snare polypectomy. Adenomas were found in 68% of lesions overall and in 84% of lesions >2 cm. Successful resection was accomplished in 93% of cases on the initial attempt. Multiple endoscopies were needed in 5% of cases. The overall complete resection rate was 98%. Recurrence was documented in 37% of cases. Complications occurred in 5.2% of patients. Polyps of >2 cm were associated with higher rates of adenoma and a higher incidence of recurrence. Colon adenomas were found in 53% of patients with duodenal adenomas. LIMITATIONS: Retrospective review. Not all patients underwent colonoscopy. CONCLUSION: NAD polyps were large, sessile, and more commonly found in the second portion of the duodenum. They are more likely to be adenomatous when the lesion size is >2 cm. Despite successful endoscopic management, over one third of lesions demonstrated recurrence.