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Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy

NCT04847167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-02-21

No results posted yet for this study

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

Interventions

PROCEDURE

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

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.

Sponsors & Collaborators

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Min Jae Yang, MD, PhD · Ajou University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-24
Primary Completion
2021-12-20
Completion
2021-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847167 on ClinicalTrials.gov