A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000014784
• Date of registration: 15/08/2014
• Prospective Registration: Yes
• Primary sponsor: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
• Public title: A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction
• Scientific title: A randomized controlled trial to compare antireflux metal stent and conventional covered metal stent for nonresectable distal malignant biliary obstruction - ARMS as the initial SEMS
• Date of first enrolment: 2014/08/20
• Target sample size: 104
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017189
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Hiroyuki Isayama
• Affiliation: Graduate School of Medicine, The University of Tokyo Department of Gastroenterology,

• Name: Hiroyuki Isayama
• Affiliation: Graduate School of Medicine, The University of Tokyo Department of Gastroenterology,

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1. Endoscopic approach to the biliary system is impossible 2. Hilar biliary obstruction 3. Performance status is four 4. Gastrointestinal obstruction distal to the papilla (patients whose gastrointestinal obstruction was resolved via a stent or surgical bypass can be included) 5. Severe comobidities in other organs 6. Pregnant women or those suspected of pregnancy 7. Written informed consent not obtained 8. Patients considered ineligible by attending physicians

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Nonresectable distal malignant biliary obstruction

Intervention(s)

Endoscopic placement of antireflux metal stent for biliay obstruction
Endoscopic placement of conventional covered metal stent for biliay obstruction

Primary Outcome(s)

Time to recurrent biliary obstrution after the placement of metal stent

Source(s) of Monetary Support

Century Medical, Inc.

Ethics review

Status: YES
Approval date: 06/08/2014
Contact:

Results

• Results available: Yes
• Date Completed: 31/12/2016