Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.

Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture. - Exploratory clinical trial evaluating the efficacy of covered self-expandable metallic stent with a removal string for benign biliary and pancreatic stricture.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022164

Enrollment

Registered

2016-07-15

Start date

2016-07-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Benign biliary stricture and benign pancreatic stricture

Interventions

Insert a covered self-expandable metallic stent with a removal string (Niti-S Kaffes stent, Taewoong medical, Korea) into benign biliary and pancreatic stricture for 90 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Benign biliary stricture and benign pancreatic stricture (post-operative biliary stricture, post-liver transplantation bilio-biliary anastomotic stricture, biliary stricture by chronic pancreatitis, pancreatic stricture by chroninc pancreatitis, anastomotic stricture after choledochojejunostomy, and anastomotic stricture after pancreaticojejunostomy). 2. Patients with refractory stricture. (Stricture resolution was not achieved after 6 months of treatment by plastic stent insertion or PTBD insertion). 3. Malignant biliary or pancreatic stricture is ruled out by pathological examination and clinical course. 4. Patients with written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with difficulty in endoscopic approach to strictures. 2. Patients withpossibility of malignant biliary or pancreatic stricture. 3. Patients with performance status 3-4. 4. Patients with serious concomitant diseases such as heart failure, respiratory failure, or disturbance of consciousness and who cannot tolerate endoscopic procedures. 5. Patients considered ineligible by the attending physician.

Design outcomes

Primary

Measure	Time frame
Rate of stricture resolution at stent removal after 90 days of indwelling.	—

Secondary

Measure	Time frame
1.Overall rate of stricture resolution at the end of the study period. 2.Rate of stricture recurrence and period until stricture recurrence. 3.Success rate of stent removal. 4.Adverse event at stent removal. 5.Other adverse events.	—

Countries

Japan

Contacts

Public ContactTatsuya Tatsuya

Graduate School of Medicine, The University of Tokyo Department of Gastroenterology

tatsusatou-tky@umin.org03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026