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The effect and safety of a modified EUS-guided NOTES intervention for refractory benign biliary obstruction in patients with surgically altered anatomy.

The effect and safety of a modified EUS-guided NOTES intervention for refractory benign biliary obstruction in patients with surgically altered anatomy.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078033
Enrollment
Unknown
Registered
2023-11-27
Start date
2023-11-30
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Refractory benign biliary obstruction in patients with surgically altered anatomy.

Interventions

Treatment group:Firstly, a temporally fistula is created under EUS guidance between the stomach and the biliary tract. The left lobe of the liver was carefully examined using EUS for evaluating the ac

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Aged between 18 and 90 years old; 2. A refractory biliary benign obstruction confirmed by clinical and image examination in patients with surgically altered anatomy; 3.Standard ERCP, colonoscopy-assisted or enteroscopy-assisted ERCP failed; 4. Informed consent of the patient's family to participate in the study and consent to participate in the study. *Refractory biliary benign obstruction is defined as follows: standard ERCP fails due to challenging common bile duct stones (=1.5cm), or severe stenosis of a choledochojejunal anastomosis.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will not be included in the study; 1. Those who cannot tolerate endoscopy; 2. Patients with endoscopy or anesthesia contraindications; 3. Coagulation dysfunction; 4. Under 18 years old or over 90 years old; 5. Join other clinical trials 3 months before onset; 6. Pregnant or lactating women; 7. Refusing to participate in clinical research; 8. Patients with serious postoperative complications such as abdominal infections, abscesses, or massive ascites.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events;

Secondary

MeasureTime frame
Treatment effectiveness (clinical success rate and technical success rate);Operation time;Duration of biliary drainage patency;

Countries

China

Contacts

Public ContactBaiwen Li

Shanghai General Hospital, Shanghai Jiao Tong University

libaiwen@163.com+86 189 3089 4343

Outcome results

None listed

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