Impact of observational training on endoscopic mucosal resection outcomes and competency for large colorectal polyps: single endoscopist experience.

Background and study aims Endoscopic mucosal resection (EMR) is standard treatment for large colorectal polyps. However, it is a specialized technique with limited data on the effectiveness of training methods to acquire this skill. The aim of this study was to evaluate the impact of observational training on EMR outcomes and competency in an early-stage endoscopist. Patients and methods A single endoscopist completed comprehensive EMR training, which included knowledge acquisition and direct observation of EMR cases, and proctored supervision, during the third year of gastroenterology fellowship. After training, EMR was independently attempted on 142 consecutive, large (i. e., ≥ 20 mm), non-pedunculated colorectal polyps between July 2014 and December 2017 (mean age 61.7 years; mean polyp size 30.4 mm; en-bloc resection 55 %). Surveillance colonoscopy for evaluation of residual neoplasia was available for 86 % of the cases. Three primary outcomes were evaluated: endoscopic assessment of complete resection, rate of adverse events (AEs), and rate of residual neoplasia on surveillance colonoscopy. Results Complete endoscopic resection was achieved in 93 % of cases, the rates of AEs and residual neoplasia were 7.8 % and 7.3 %, respectively. The rate of complete resection remained stable (at 85 % or greater) with increasing experience while rates of AEs and residual neoplasia peaked and decreased after 60 cases. Conclusions An early-stage endoscopist can acquire the skills to perform effective EMR after completing observational training. At least 60 independent EMRs for large colorectal polyps were required to achieve a plateau for clinically meaningful outcomes.

Endoscopic ultrasound-guided biliary access versus precut papillotomy in patients with failed biliary cannulation: a retrospective study.

Background and aims Precut papillotomy is widely used after failed biliary cannulation. Endoscopic ultrasound (EUS)-guided biliary access techniques are newer methods to facilitate access and therapy in failed cannulation. We evaluated the impact of EUS-guided biliary access on endoscopic retrograde cholangiopancreatography (ERCP) success and compared these techniques to precut papillotomy. Patients and methods We retrospectively compared two ERCP cohorts. One cohort consisted of biliary ERCPs (n = 1053) attempted in patients with native papillae and surgically unaltered anatomy in whom precut papillotomy and/or EUS-guided biliary access were routinely performed immediately after failed cannulation. This cohort was compared with a similar ERCP cohort (n = 1062) in which only precut papillotomy was available for failed cannulation. The following outcomes were compared: conventional cannulation success, rates of attempted advanced access techniques (precut or EUS), precut success, EUS-guided biliary access success, and ERCP failure rates. Results Although conventional cannulation success, rates of attempted advanced access technique (precut or EUS), and precut success were similar, the ERCP failure rate was lower when both EUS-guided biliary access and precut were available (1.0 % [95 % confidence interval (CI) 0.4 - 1.6]), compared with when only precut was possible for failed access (3.6 % [95 %CI 2.5 - 4.7]; P < 0.001). Success for EUS-guided biliary access (95.1 % [95 %CI 89.7 - 100]) was significantly higher than for precut (75.3 % [95 %CI 68.2 - 82.4]; P < 0.001), and mainly due to superiority in malignant obstruction (93.5 % vs. 64 %; P < 0.001). Conclusions EUS-guided biliary access decreases the rate of therapeutic biliary ERCP failure. Our results support the use of EUS-guided biliary access to optimize single-session ERCP success. In experienced hands, these techniques appear as effective, if not more so, than precut papillotomy.

A randomized controlled cross-over trial and cost analysis comparing endoscopic ultrasound fine needle aspiration and fine needle biopsy.

BACKGROUND AND STUDY AIMS: Techniques to optimize endoscopic ultrasound-guided tissue acquisition (EUS-TA) in a variety of lesion types have not yet been established. The primary aim of this study was to compare the diagnostic yield (DY) of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) to endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for pancreatic and non-pancreatic masses. PATIENTS AND METHODS: Consecutive patients referred for EUS-TA underwent randomization to EUS-FNA or EUS-FNB at four tertiary-care medical centers. A maximum of three passes were allowed for the initial method of EUS-TA and patients were crossed over to the other arm based on on-site specimen adequacy. RESULTS: A total of 140 patients were enrolled. The overall DY was significantly higher with specimens obtained by EUS-FNB compared to EUS-FNA (90.0 % vs. 67.1 %, P = 0.002). While there was no difference in the DY between the two groups for pancreatic masses (FNB: 91.7 % vs. FNA: 78.4 %, P = 0.19), the DY of EUS-FNB was higher than the EUS-FNA for non-pancreatic lesions (88.2 % vs. 54.5 %, P = 0.006). Specimen adequacy was higher for EUS-FNB compared to EUS-FNA for all lesions (P = 0.006). There was a significant rescue effect of crossover from failed FNA to FNB in 27 out of 28 cases (96.5 %, P = 0.0003). Decision analysis showed that the strategy of EUS-FNB was cost saving compared to EUS-FNA over a wide range of cost and outcome probabilities. CONCLUSIONS: RESULTS of this RCT and decision analysis demonstrate superior DY and specimen adequacy for solid mass lesions sampled by EUS-FNB.

Feasibility of nonradiation EUS-based ERCP in patients with uncomplicated choledocholithiasis (with video).

BACKGROUND AND AIMS: ERCP inherently involves radiation exposure. Nonradiation ERCP has been described in pregnancy. Theoretically, the same techniques could be applied to the general population. We prospectively assessed the feasibility of nonradiation, EUS-based ERCP in nonpregnant patients with choledocholithiasis. METHODS: Consecutive patients referred for ERCP for choledocholithiasis were recruited over a 1-year period. Patients providing study consent underwent the following procedural protocol. First, EUS was performed to verify the presence, size, and number of stones. Second, biliary cannulation was attempted without fluoroscopy for a maximum of 10 minutes. Selective cannulation was based on deep insertion with visible bile in the catheter on aspiration. Third, for stone removal, sphincterotomy was performed and stones were removed using a basket or balloon. The number of stones exiting the papilla was matched to the number seen on EUS. Finally, once the duct was deemed clear by the endoscopist, a final occlusion cholangiogram and ductal sweep served as the reference standard for confirmation of stone clearance. RESULTS: Nonradiation ERCP was attempted in 31 patients. Cannulation without fluoroscopy was successful in 26 patients (84%). Complete stone removal without fluoroscopy was achieved in all 26 of these cases. The 5 patients with failed nonfluoroscopic cannulation required double guidewire (n = 2) or precut papillotomy (n = 3) for deep biliary access and subsequent stone clearance. One patient who required precut papillotomy for access developed moderate post-ERCP pancreatitis (3%). CONCLUSIONS: Nonradiation, EUS-based ERCP for uncomplicated choledocholithiasis appears to be successful and safe. (Clinical trial registration number: NCT01678391.).

EUS-guided drainage of peripancreatic fluid collections and necrosis by using a novel lumen-apposing stent: a large retrospective, multicenter U.S. experience (with videos).

BACKGROUND AND AIMS: EUS-guided drainage of peripancreatic fluid collection (PFC) (pancreatic pseudocyst [PP] or walled-off necrosis [WON]) by using a novel lumen-apposing, fully covered, self-expandable metal stent (LAMS) has been promising, but few of these data are from the United States. The aim of this study was to evaluate clinical outcomes and safety of EUS-guided drainage of pancreatic pseudocysts and WON by using the LAMS. METHODS: We conducted a multicenter, retrospective study on 82 patients with symptomatic PFC who underwent EUS-guided drainage by using the LAMS at 4 U.S. tertiary care centers. Outcomes evaluated included successful placement of the LAMS, the number of patients in whom complete resolution of PPs or WON was achieved, the number of procedures performed per patient to achieve PFC resolution, and adverse events. RESULTS: The mean size of the PFC was 11.8 cm. LAMSs were successfully placed in 80 patients (97.5%). Twelve patients had PP and 68 had WON. The median stent in-dwelling time was 2 months (range 1-3 months). Endoscopic debridement with the LAMS in WON was performed in 54 patients. The patency of the stent was maintained in 98.7% of the patients (77/78). There was spontaneous dislodgment of 2 LAMSs. Successful endoscopic therapy by using the LAMS was successful in 12 of 12 patients (100%) with PP compared with 60 of 68 patients (88.2%) with WON. All stents were endoscopically removed from all patients after peripancreatic fluid collection (PFC) resolution. There was 1 PFC recurrence during the 3-month median follow-up period. Procedure-related adverse events occurred in 8 patients (9.8%), and included stent maldeployment (n = 2), and self-limited bleeding (n = 6). In 1 patient with stent maldeployment gastric perforation developed, and the patient underwent surgical repair. CONCLUSION: EUS-guided drainage of PFCs by using the novel LAMS has high technical and long-term success rates. Due to its ease of use, the LAMSs may simplify and streamline EUS-guided management of PFCs, particularly for the endoscopic debridement of WON, and may help in its widespread adoption as an alternative to surgery.

Underwater EMR of adenomas of the appendiceal orifice (with video).

BACKGROUND AND AIMS: EMR of adenomas involving the appendiceal orifice (AO) is controversial because of a high risk of perforation and incomplete resection. We evaluated the feasibility, safety, and outcomes of underwater EMR (UEMR) without submucosal injection for the treatment of adenomas involving the AO. METHODS: This was a prospective, observational study of a standardized UEMR technique without submucosal injection for adenomas involving the AO in 27 consecutive patients meeting inclusion and exclusion criteria. Surveillance colonoscopy included biopsy sampling of the EMR site and base of the AO. Main outcome measurements include technical success, histology, resection time, adverse events, and follow-up data. RESULTS: Over 42 months, UEMR of adenomas involving the AO (rim, 5 patients; inside, 22 patients) was attempted in 27 consecutive patients. Median adenoma size was 15 mm (range, 8 to 50). UEMR was successful in 24 patients (89%). Four patients were referred to surgery, 3 with UEMR failure because of an inability to exclude the adenoma extending into the appendix at the index procedure and 1 with invasive adenocarcinoma in the UEMR specimen. The median resection time was 3 minutes (range, 1 to 75). Adverse events consisted of postpolypectomy syndrome in 2 patients (7%). There was no perforation, bleeding requiring transfusion, or appendicitis. Final histology was tubular adenoma (7), tubulovillous adenoma (4), sessile serrated adenoma (15), and invasive adenocarcinoma (1). Twenty-one of 23 patients (91%), not referred to surgery, had follow-up colonoscopy with biopsy sampling of the resection site after a median of 29 weeks (range, 12 to 139) after resection. Residual adenoma was found in 2 of 21 patients (10%). CONCLUSION: On an intention-to-treat basis, UEMR without submucosal injection enabled safe and complete endoscopic resection of AO lesions. Close surveillance for residual or recurrence is warranted. ( CLINICAL TRIALS REGISTRATION NUMBER: NCT01750619.).

EUS-guided treatment of gastric fundal varices with combined injection of coils and cyanoacrylate glue: a large U.S. experience over 6 years (with video).

BACKGROUND AND AIMS: Conventional endoscopic treatment of gastric fundal varices (GFV) with cyanoacrylate (CYA) glue may be complicated by embolization and rebleeding. We evaluated the long-term outcomes of EUS-guided injection of coils and CYA glue for therapy of GFV. METHODS: A retrospective chart review of patients treated for GFV was performed. The main outcomes measured were hemostasis, obliteration on surveillance EUS, post-treatment bleeding rate, and adverse events. RESULTS: From March 2009 to 2015, 152 patients with GFV were treated. Seven (5%) had active hemorrhage, 105 (69%) had recent bleeding, and 40 (26%) were treated for primary prophylaxis. Treatment was technically successful in 151 patients (>99%). Mean number of coils was 1.4 (range, 1-4 coils), and mean volume of CYA was 2 mL (range, 0.5-6). Follow-up was available for 125 patients with treated GFV (mean, 436 days; range, 30-2043). Among 100 patients with follow-up EUS examinations, complete obliteration (on Doppler study) of GFV was confirmed in 93 (93%). Post-treatment bleeding from obliterated GFV occurred in 3 of 93 patients (3%). Twenty-five patients who had clinical and/or EGD follow-up had 3 post-treatment bleeding episodes after a median follow-up of 324 days (range, 41-486). Among the 40 patients treated for primary prophylaxis, 28 underwent follow-up EUS and 27 (96%) had confirmed obliteration. Mild postprocedure abdominal pain occurred in 4 of 125 patients (3%), and clinical signs of pulmonary embolization were seen in 1 patient (1%). Another 4 of 125 patients (3%) presented with minor delayed upper GI bleeding from coil/glue extrusion. CONCLUSIONS: EUS-guided combined coil and CYA glue injection of high-risk GFV appears to be highly effective for hemostasis in active bleeding and primary and secondary bleeding prophylaxis. Once obliteration was achieved, post-treatment bleeding from GFV occurred in only 3% during long-term follow-up. Combination therapy appears safe and may reduce the risk of CYA embolization.

Control of acid and duodenogastroesophageal reflux (DGER) in patients with Barrett's esophagus.

OBJECTIVES: Symptom eradication in patients with Barrett's esophagus (BE) does not guarantee control of acid or duodenogastroesophageal reflux (DGER). Continued reflux of acid and/or DGER may increase risk of neoplastic progression and may decrease the likelihood of columnar mucosa eradication after ablative therapy. To date, no study has addressed whether both complete acid and DGER control is possible in patients with BE. This prospective study was designed to assess the effect of escalating-dose proton pump inhibitor (PPI) therapy on esophageal acid and DGER. METHODS: Patients with BE (≥3 cm in length) underwent simultaneous ambulatory prolonged pH and DGER monitoring after at least 1 week off PPI therapy followed by testing on therapy after 1 month of twice-daily rabeprazole (20 mg). In those with continued acid and/or DGER, the tests were repeated after 1 month of double-dose (40 mg twice daily) rabeprazole. The primary study outcome was normalization of both acid and DGER. Symptom severity was assessed on and off PPI therapy employing a four-point ordinal scale. RESULTS: A total of 29 patients with BE consented for pH monitoring, of whom 23 also consented for both pH and DGER monitoring off and on therapy (83% male; mean age 58 years; mean body mass index 29; mean Barrett's length 6.0 cm). Median (interquartile range) total % time pH <4 and bilirubin absorbance >0.14 off PPI therapy were 18.4 (11.7-20.0) and 9.7 (5.0-22.2), respectively. In addition, 26/29 (90%) had normalized acid and 18/23 (78%) had normalized DGER on rabeprazole 20 mg. Among those not achieving normalization on 20 mg twice daily, 3/3 (100%) had normalized acid and 4/5 (80%) had normalized DGER on rabeprazole 40 mg twice daily. All subjects had symptoms controlled on rabeprazole 20 mg twice daily. Univariate analysis found no predictor for normalization of physiologic parameters based on demographics. CONCLUSIONS: Symptom control does not guarantee normalization of acid and DGER at standard dose of twice-daily PPI therapy. Normalization of acid and DGER can be achieved in 79% of BE patients on rabeprazole 20 mg p.o. twice daily, and in the majority of the remainder at high-dose twice-daily PPI. In patients undergoing ablative therapy, pH or DGER monitoring may not be needed to ensure normalization of reflux if patients are treated with high-dose PPI therapy.

Attempted underwater en bloc resection for large (2-4 cm) colorectal laterally spreading tumors (with video).

OBJECTIVE: To evaluate the feasibility and outcomes of attempted underwater en bloc resection (UEBR) of large colorectal laterally spreading tumors (LSTs). DESIGN: Prospective, observational study. SETTING: Tertiary academic referral center. PATIENTS: Fifty patients meeting the inclusion and exclusion criteria. INTERVENTIONS: Standardized UEBR technique involving attempted en bloc resection without submucosal injection by using a large 33-mm snare. MAIN OUTCOME MEASUREMENTS: Complete endoscopic en bloc resection, histologic complete resection, procedure time, adverse events, and follow-up data. RESULTS: Over 13 months, UEBR was attempted in 50 patients (median age, 68 years) with 53 LSTs 2 to 4 cm in size. The median LST size was 30 mm (range 20-40 mm). The median procedure and resection times were 38 minutes (range 17-87 minutes) and 3 minutes (range 1-32 minutes), respectively. Complete endoscopic en bloc resection with the 33-mm snare was successful in 29 of 53 lesions (55%). Of these, histology showed neoplasia-free margins in 79%. Final histology was tubular adenoma (n = 26), sessile serrated adenoma (n = 10), tubulovillous adenoma (n = 14), villous adenoma (n = 2), and intramucosal carcinoma (n = 1). Adverse events (4%) were delayed bleeding in 1 and abdominal pain in 1 patient each. There were no perforations. Forty patients with a total of 43 adenomas had follow-up colonoscopy with biopsies of the resection site after a median of 31 weeks (range 7-71 weeks) after resection. Residual adenoma was found in 2 of 43 (5%). LIMITATIONS: Single-center, limited follow-up. CONCLUSION: On an intention-to-treat basis, complete endoscopic en bloc resection was achieved in 55% of lesions with complete histologic resection verified in 79% of the en bloc specimens. UEBR without submucosal injection appears safe. Refinements are needed to improve UEBR success rates.

Electronic chromoendoscopy.

Electronic chromoendoscopy technologies provide image enhancement and may improve the diagnosis of mucosal lesions. Although strides have been made in standardization of image characterization, especially with NBI, further image-to-pathology correlation and validation are required. There is promise for the development of a resect and discard policy for diminutive adenomas by using electronic chromoendoscopy; however, before this can be adopted, further community-based studies are needed. Further validated training tools for NBI, FICE, and i-SCAN will also be required for the use of these techniques to become widespread.

EUS-FNA is superior to ERCP-based tissue sampling in suspected malignant biliary obstruction: results of a prospective, single-blind, comparative study.

BACKGROUND: Both EUS and ERCP sampling techniques may provide tissue diagnoses in suspected malignant biliary obstruction. However, there are scant data comparing these 2 methods. OBJECTIVE: To compare EUS-guided FNA (EUS-FNA) and ERCP tissue sampling for the diagnosis of malignant biliary obstruction. DESIGN: Prospective, comparative, single-blind study. SETTING: Tertiary center. PATIENTS: Fifty-one patients undergoing same-session EUS and ERCP for the evaluation of malignant biliary obstruction over a 1-year period. INTERVENTIONS: EUS-FNA and ERCP tissue sampling with biliary brush cytology and intraductal forceps biopsies. MAIN OUTCOME MEASUREMENTS: Diagnostic sensitivity and accuracy of each sampling method compared with final diagnoses. RESULTS: EUS-FNA was more sensitive and accurate than ERCP tissue sampling (P < .0001) in 51 patients with pancreatic cancers (n = 34), bile duct cancers (n = 14), and benign biliary strictures (n = 3). The overall sensitivity and accuracy were 94% and 94% for EUS-FNA, and 50% and 53% for ERCP sampling, respectively. EUS-FNA was superior to ERCP tissue sampling for pancreatic masses (sensitivity, 100% vs 38%; P < .0001) and seemed comparable for biliary masses (79% sensitivity for both) and indeterminate strictures (sensitivity, 80% vs 67%). LIMITATIONS: Single-center study. CONCLUSION: EUS-FNA is superior to ERCP tissue sampling in evaluating suspected malignant biliary obstruction, particularly for pancreatic masses. EUS-FNA appears similar to ERCP sampling for biliary tumors and indeterminate strictures. Given the superior performance characteristics of EUS-FNA and the higher incidence of pancreatic cancer compared with cholangiocarcinoma, EUS-FNA should be performed before ERCP in all patients with suspected malignant biliary obstruction. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01356030.).

Suck-ligate-unroof-biopsy by using a detachable 20-mm loop for the diagnosis and therapy of small subepithelial tumors (with video).

BACKGROUND: The diagnosis and therapy of subepithelial tumors (SETs) can be challenging. OBJECTIVE: Proof-of-concept evaluation of the suck-ligate-unroof-biopsy (SLUB) technique for small (<2 cm), non-pedunculated SETs. DESIGN: Pilot feasibility study. SETTING: Tertiary-care referral center. PATIENTS: Twenty-three patients (median age 60 years) meeting the inclusion criteria after preliminary EUS. INTERVENTION: SET ligation was performed with a detachable 20-mm loop deployed through an 18-mm diameter, soft, oblique, transparent, cap attachment. The SLUB technique comprised (1) suction to draw the SET into the cap; (2) ligation below the SET, confirmation by repeat EUS; (3) unroofing of the overlying mucosa with a needle-knife; and (4) biopsy specimens taken from the exposed tumor. MAIN OUTCOME MEASUREMENTS: Technical success, histology and/or immunohistochemistry yield, adverse events, completeness of resection. RESULTS: SLUB was attempted on 24 SETs and was technically successful in all. Location was the stomach (n = 19), small bowel (n = 1), colon (n = 2), and rectum (n = 2). Median size by EUS was 10 mm (range 6-15 mm). Biopsy specimens provided an immunohistologic diagnosis in all cases: GI stromal tumor (n = 5), leiomyoma (n = 8), carcinoid tumor (n = 5), Vanek's tumor (n = 2), granuloma (n =1), and pancreatic heterotopia (n = 3). Follow-up endoscopy and EUS in 13 patients showed well-healed scars with no residual tumor, including all 9 patients with premalignant neoplastic lesions. The only adverse event was self-limited pain in 2 patients. LIMITATIONS: Single center, single operator, small sample size. CONCLUSIONS: Loop ligation of small, non-pedunculated SETs is feasible by using a cap attachment for suction. Unroofing after ligation is safe and provides sufficient tissue for immunohistochemistry. Ligation combined with unroofing appears to lead to complete ablation by ischemia and tumor enucleation.

Devices for the endoscopic treatment of hemorrhoids.

Multiple endoscopic methods are available to treat symptomatic internal hemorrhoids. Because of its low cost, ease of use, low rate of adverse events, and relative effectiveness, RBL is currently the most widely used technique.