A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

• ClinicalTrials.gov Identifier: NCT02659852
• Recruitment Status: Unknown
• First Posted: January 20, 2016
• Last Update Posted: January 28, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: January 12, 2016
• First Posted Date: January 20, 2016
• Last Update Posted Date: January 28, 2019
• Study Start Date: January 2016
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2016)

Median patency duration [ Time Frame: 1 year after stent insertion ]

Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 19, 2016)

• Overall survival [ Time Frame: 1 year ]
• complication rate [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
• Official Title: A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

Brief Summary

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.

The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cholangiocarcinoma
• Gallbladder Cancer
• Pancreatic Cancer
• HCC
• AOV Cancer

Intervention

• Procedure: side by side
  Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.
• Procedure: stent in stent
  After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.

Study Arms

• Experimental: Side by side group
  Intervention: Procedure: side by side
• Active Comparator: Stent in stent group
  Intervention: Procedure: stent in stent

Publications *

• Law R, Baron TH. Bilateral metal stents for hilar biliary obstruction using a 6Fr delivery system: outcomes following bilateral and side-by-side stent deployment. Dig Dis Sci. 2013 Sep;58(9):2667-72. doi: 10.1007/s10620-013-2671-4. Epub 2013 Apr 27.
• Kim KM, Lee KH, Chung YH, Shin JU, Lee JK, Lee KT, Shim SG. A comparison of bilateral stenting methods for malignant hilar biliary obstruction. Hepatogastroenterology. 2012 Mar-Apr;59(114):341-6. doi: 10.5754/hge11533.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 19, 2016): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2020
• Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
• older than 20 years old

Exclusion Criteria:

• Operable case
• Non-hilar biliary malignant obstruction
• Duodenal obstruction
• Other cancer except biliary malignancy
• uncontrolled infection status
• Eastern Cooperative Oncology Group ≥ 3
• No signed informed consent
• Failed endoscopic approach to duodenum or biliary tract

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02659852
• Other Study ID Numbers: 4-2015-1072
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: January 2019