Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy

NCT04847167 | Completed

• 1 other identifier: 20-611
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is the current standard technique for the treatment of pancreatobiliary disease. However, ERCP in patients with a surgically altered anatomy (SAA) remains a challenge. The short-type balloon enteroscope dedicated to pancreatobiliary intervention was recently introduced and has gained popularity as a primary modality for ERCP in patients with SAA. The currently available short-type single-balloon enteroscope (SBE) has a 3.2-mm enlarged diameter for the working channel and a 152-cm shortened working length, which can accommodate most conventional ERCP accessories and stent assemblies, and it is equipped with high-force transmission and passive bending, which facilitate passing the sharply angulated bowel segment. However, Roux-en-Y (R-Y) reconstruction anatomy is still challenging for the pancreatobiliary physician with regard to ERCP owing to the long length of the Roux and pancreatobiliary limb, and bowel angulations around the jejunojejunal anastomosis. The pooled procedural success of short SBE-assisted ERCP (SBE-ERCP) for R-Y reconstruction was reported to be 76.4% in a recent metaanalysis. The most important factor for procedural success and safety of short SBE-ERCP for R-Y patients is to resolve and prevent various bowel types looping through the collaborative manipulation of an enteroscope and overtube. In the clinical field, there is an unmet need for a formulaic loop-handing technique that can be applied to most cases of R-Y reconstruction. Therefore, in the current study, we aimed to evaluate the efficacy and safety of a mechanistic loop resolution strategy for short SBE-ERCP in patients undergoing R-Y reconstruction.

Conditions

Choledocholithiasis; Bile Duct Neoplasms; Biliary Tract Diseases; Roux-en-Y Anastomosis

Outcome Measures

Primary Outcomes (1)

• Enteroscopy success rate

  The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients

  During procedure

Secondary Outcomes (1)

• Therapeutic success rate

  During procedure

Study Arms (1)

Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group

EXPERIMENTAL

All ERCP was performed with the patient in the prone position using a SBE (SIF-H290S; Olympus Corp., Japan) under CO2 insufflation and conscious sedation. A soft transparent hood (D-201-11804; Olympus Corp., Japan) was used in all cases. The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire.

Procedure: Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group

Interventions

Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group PROCEDURE

The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire.

Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a previous R-Y reconstruction
• Clinical and radiological diagnosis of biliary obstruction

You may not qualify if:

• Coagulopathy (International normalized ratio \>1.5, platelet count \<50,000)
• Peritoneal carcinomatosis.

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Gyeonggido, 443-380, South Korea

Location

Related Publications (1)

• Yang MJ, Kim JH, Hwang JC, Yoo BM, Park SW, Kwon CI, Jeong S. Mechanistic loop resolution strategy for short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with Roux-en-Y reconstruction after gastrectomy (with video). Surg Endosc. 2022 Nov;36(11):8690-8696. doi: 10.1007/s00464-022-09575-2. Epub 2022 Sep 22.

  PMID: 36136178 DERIVED

MeSH Terms

Conditions

Choledocholithiasis; Bile Duct Neoplasms; Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Digestive System Diseases; Cholelithiasis; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Min Jae Yang, MD, PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 19, 2021
• Study Start: February 24, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)