Pure Cut or Endocut for Biliary Sphincterotomy? A Multicenter Randomized Clinical Trial.

INTRODUCTION: Adverse events (AE) after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and post-ERCP acute pancreatitis (PEP) is the most important one. Thermal injury from biliary sphincterotomy may play an important role and trigger PEP or bleeding. Therefore, this study evaluated the outcomes of 2 electric current modes used during biliary sphincterotomy. METHODS: From October 2019 to August 2021, consecutive patients with native papilla undergoing ERCP with biliary sphincterotomy were randomized to either the pure cut or endocut after cannulation. The primary outcome was PEP incidence. Secondary outcomes included intraprocedural and delayed bleeding, infection, and perforation. RESULTS: A total of 550 patients were randomized (272 pure cut and 278 endocut). The overall PEP rate was 4.0% and significantly higher in the endocut group (5.8% vs 2.2%, P = 0.034). Univariate analysis revealed >5 attempts ( P = 0.004) and endocut mode ( P = 0.034) as risk factors for PEP. Multivariate analysis revealed >5 attempts ( P = 0.005) and a trend for endocut mode as risk factors for PEP ( P = 0.052). Intraprocedural bleeding occurred more often with pure cut ( P = 0.018), but all cases were controlled endoscopically during the ERCP. Delayed bleeding was more frequent with endocut ( P = 0.047). There was no difference in perforation ( P = 1.0) or infection ( P = 0.4999) between the groups. DISCUSSION: Endocut mode may increase thermal injury leading to higher rates of PEP and delayed bleeding, whereas pure cut is associated with increased intraprocedural bleeding without clinical repercussion. The electric current mode is not related to perforation or infection. Further RCT assessing the impact of electric current on AE with overlapping preventive measures such as rectal nonsteroidal anti-inflammatory drugs and hyperhydration are needed. The study was submitted to the Brazilian Clinical Trials Platform ( http://www.ensaiosclinicos.gov.br ) under the registry number RBR-5d27tn.

Does it matter which plastic stents we use for the treatment of post-surgical leaks? Or does one-size-fit-all?

We congratulate Fuentes-Valenzuela et al. on their study entitled "Endoscopic internal drainage using transmural double-pigtail stents in leaks following upper gastrointestinal tract surgery." The authors report a technical and clinical success of 100 % and 77.8 %, respectively. Although double-pigtail stents (DPS) have been a mainstay in the treatment of leaks and post-surgical fluid collections, we would like to share our reservations with the type of DPS used.

Robot-assisted endoscopic submucosal dissection versus conventional ESD for colorectal lesions: outcomes of a randomized pilot study in endoscopists without prior ESD experience (with video).

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is becoming the preferred method for certain early GI malignancies; however, very few U.S. physicians have adopted this technique. This is in part because of the technically challenging nature of the procedure and the long learning curve. Several endoscopic robots are under development to address these complexities. METHODS: This is a randomized, controlled, pilot study comparing conventional ESD versus robotic-assisted ESD (RESD) in an ex vivo bovine colon model. Five endoscopists without prior ESD or RESD experience were randomized into 2 groups (group 1, RESD after ESD; group 2, RESD before ESD). A standard template was used to create colonic lesions. The primary outcome was completeness of en bloc resection. Secondary outcomes included differences in procedure time, perforation rate, muscle injury rate, and National Aeronautical and Space Administration Task Load Index (NASA-TLX) to assess physical and mental workload. RESULTS: Five endoscopists each performed 4 tissue resections (2 RESD and 2 ESD), for a total of 20 procedures. Complete en bloc resection was achieved in all RESD and in 50% of ESD (P < .0001). The perforation rate was higher in the ESD group (60% vs 30%, P = .18). Total procedure time (34.1 vs 88.6 min, P = .001) and dissection time (27.8 vs 79.4 minutes, P = .002) were lower for RESD. The NASA-TLX also revealed better results for RESD (28.4 vs 47.4, P = .01). CONCLUSIONS: RESD appears to be more effective in obtaining en bloc resection with shorter procedure times and a lower perforation rate compared with conventional ESD as performed by ESD novices. RESD is also associated with lower physical and mental workloads.