Two-in-one Covered and Uncovered Metal Stent

NCT04337333 | Unknown

• 1 other identifier: AJIRB-DEV-INT-20-035
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency. To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced. In the current study, the investigators aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.

Conditions

Extrahepatic Bile Duct Cancer; Pancreatic Cancer; Lymph Node Metastases; Gallbladder Cancer

Outcome Measures

Primary Outcomes (1)

• Cumulative patency of inner covered stent and Two-in-one stent

  From the date of stent insertion until the date of first documented stent dysfunction, assessed upto 12 months

Secondary Outcomes (2)

• Overall patient survival

  From the date of stent insertion until the date of death from any cause, assessed upto 12 months

• Stent dysfunction-free patient survival

  From the date of stent insertion until the date of first documented stent dysfunction or the date of death from any cause, whichever came first, assessed up to 12 months

Study Arms (1)

Two-in-one stent

OTHER

Endoscopic placement of a Two-in-one stent into the extrahepatic bile duct, considering the longitudinal location of the stricture segment and predicted safety margin

Device: Two-in-one stent

Interventions

Two-in-one stent DEVICE

Endoscopic placement of a Two-in-one metal stent into extrahepatic bile duct

Two-in-one stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ㆍMalignant biliary obstruction, 2 cm distal to the hilum ㆍNot eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ㆍEastern Cooperative Oncology Group Performance status 0-3

You may not qualify if:

• ㆍBeing evaluated for potential benign biliary stricture or possible operation ㆍHistory of biliary surgery except cholecystectomy ㆍCoagulopathy (International normalized ratio \>1.5, platelet count \<50,000) ㆍCoexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ㆍInability to obtain informed consent

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (2)

Ajou University Hospital

Suwon, Gyeong Gi Do, 443-721, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggido, 443-380, South Korea

RECRUITING

MeSH Terms

Conditions

Bile Duct Neoplasms; Pancreatic Neoplasms; Lymphatic Metastasis; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gallbladder Diseases

Study Officials

• Jin Hong Kim, MD, PhD

  Ajou University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Min Jae Yang, MD, PhD

CONTACT

82-31-219-7821; creator1999@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 7, 2020
• Study Start: May 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)