Clinical trial · Interventional
Mechanistic Loop Resolution Strategy for Short-type Single Balloon Enteroscopy
Mechanistic Loop Resolution Strategy for Short-type Single-balloon Enteroscopy-assisted Endoscopic Retrograde Cholangiopancreatography in Patients With Roux-en-Y Reconstruction
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Neoplasms | Bile Duct Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Biliary Tract Diseases | — | UNRESOLVED | — |
| Choledocholithiasis | — | UNRESOLVED | — |
| Roux-en-Y Anastomosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
- description
- 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.
- interventionNames
- Procedure: Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group
Primary outcomes (1)
- measure
- Enteroscopy success rate
- timeFrame
- During procedure
- description
- The proportion of patients with successful reaching and visualizing the papilla or biliopancreatic anastomosis using a short SBE among all patients
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a previous R-Y reconstruction * Clinical and radiological diagnosis of biliary obstruction Exclusion Criteria: * Coagulopathy (International normalized ratio \>1.5, platelet count \<50,000) * Peritoneal carcinomatosis.
References
Publications (1)
- DERIVEDYang 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