Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Distal Biliary Stricture: A Multicenter Prospective Randomized Controlled Trial

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20180716005

Enrollment

Registered

2018-07-16

Start date

2016-12-26

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Hilar Obstruction Cholangiocarcinoma Migration rate of metallic stents Complication rate of metallic stents Recurrence of Biliary Obstruction while on stent

Interventions

The Multi&#45

Hole Self&#45

Expandable Metal Stent (MHSEMS) is newly designed stent to serve the purpose with multiple small holes on the wall of the MHSEMS. ,Standard self&#45

expandable metallic stents used to maintain patency of strictures (in this case&#44

biliary stricture)

Active Comparator Device,Active Comparator Device

Multi&#45

hole Self&#45

expandable Metal Stents,Fully Covered Self&#45

Expandable Metal Stents

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years 2. Patients who have been diagnosed with cholangiocarcinoma with or without histopathology 3. The upper extremity of the bile duct obstruction is at least 1 centimeter below the bile duct at the hilar (hilar). 4. The patient has never had a catheter drainage by any other means.

Exclusion criteria

Exclusion criteria: 1. Platelet count 1.5 2. Get anti-coagulant medication. 3. Pregnancy 4. Prohibited or unable to perform endoscopic cholecystectomy. 5. There is blockage of hilum. 6. It is not possible to insert a biliary catheter 7. Follow-up and Diagnosis Results After Non-Hodgkin's Disease

Design outcomes

Primary

Measure	Time frame
Recurrent Biliary Obstruction Rate of Multi-hole Metallic Stents versus Fully Covered Metallic Stent after insertion of stent recurrent biliary Obstruction Rate	—

Secondary

Measure	Time frame
Technical and clinical success rate of MHSEMS vs FCSEMS after insertion of stent migration rate	—

Countries

Thailand

Contacts

Public ContactPradermchai Kongkam

Chulalongkorn University

kongkam@hotmail.com026494003

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026

Multi&#45;Hole Self&#45;expandable Metal Stent (MHSEMS) versus Fully&#45;covered Self&#45;Expandable Metal Stent (FCSEMS) for Distal Biliary Stricture: A Multicenter Prospective Randomized Controlled Trial