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A single-center prospective single-arm cohort study of endoscopic ultrasound-directed gastrointestinal bypass-assisted ERCP versus short single balloon enteroscopy-assisted ERCP for biliary diseases after Roux-en-Y cholangiojejunostomy anastomosis

A single-center prospective single-arm cohort study of endoscopic ultrasound-directed gastrointestinal bypass-assisted ERCP versus short single balloon enteroscopy-assisted ERCP for biliary diseases after Roux-en-Y cholangiojejunostomy anastomosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071596
Enrollment
Unknown
Registered
2023-05-18
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

biliary diseases after Roux-en-Y cholangiojejunostomy anastomosis

Interventions

EDGE group:endoscopic ultrasound-directed gastrointestinal bypass-assisted ERCP
SSE-ERCP group:single balloon enteroscopy-assisted ERCP

Sponsors

Nanjing University Medical School Affiliated Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age over 18 years. (2) Prior Roux-en-Y cholangiojejunostomy anastomosis and at least 3 months postoperative. (3) ERCP was required for biliary disease. (4) Subjects voluntarily participated in this trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Acute cholangitis and other patients requiring emergency ERCP for biliary drainage. (2) Women during pregnancy. (3) Those with uncorrectable coagulation dysfunction. (4) Weight less than 40 kg. (5) Those with severe organ dysfunction or other reasons for not being able to tolerate the procedure. (6) Those who have participated or are participating in other clinical trials within the last 3 months. (7) Those who, in the judgment of the investigator, are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
clinical efficacy;

Secondary

MeasureTime frame
Success rate of reaching the biliary-intestinal anastomosis;Success rate of cannulation;Surgical success rate;Intraoperative adverse events;Total duration of operation;Radiation exposure time and dose;Length of postoperative hospital stay;cost;Postoperative complications;

Countries

China

Contacts

Public ContactBin Zhang

Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital

billzhangnju@foxmail.com+86 13601587718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026