Two-in-one Covered and Uncovered Metal Stent

NCT ID: NCT04337333

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-01
• Study Completion Date: 2021-12-31

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.

Detailed Description

Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. As the survival time for those patients has improved due mainly in part to development of chemotherapeutic intervention, it is becoming important to prevent recurrent cholangitis and liver failure by prolonging the SEMS patency, leading to continuation of chemotherapy and better prognosis. Therefore, one-time stent insertion before disease-progression-related death is an ultimate goal of developing an ideal biliary stent.

SEMSs have been found to be superior to plastic stents in terms of the stent patency, because it prevent accumulation of biliary sludge owing to larger diameter. The ideal designs of biliary SEMSs for prolongation of the stent patency include 1) bare metal mesh for tissue embedding to prevent stent migration, 2) covering material to counteract neoplastic tumor ingrowth, and 3) anti-reflux structure to reduce enteric biliary reflux. 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 field of the interventional radiology, but further data accumulation is needed to assess the comparability with various conventional SEMS types in terms of stent patency, reintervention efficacy, and clinical outcomes following reintervention, because in this system two metal stents are implanted at once exclusively via percutaneous route and clogged inner covered stent cannot be removed at the time of the reintervention. Recently a new covered and uncovered SEMS in which the clogged inner stent can be endoscopically removed leaving the outer stent in place, was introduced. In the current study, we 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Two-in-one stent

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

Group Type: OTHER

Two-in-one stent

Intervention Type: DEVICE

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

Interventions

Two-in-one stent

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jin Hong Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Hong Kim, MD, PhD

Role: STUDY_DIRECTOR

Ajou University School of Medicine

Locations

Ajou University Hospital

Suwon, Gyeong Gi Do, South Korea

Site Status: RECRUITING

Ajou University Hospital

Suwon, Gyeonggido, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Jae Yang, MD, PhD

Role: CONTACT

creator1999@hanmail.net

82-31-219-7821

Facility Contacts

Jin Hong Kim, MD, PhD

Role: primary

jinhkim@ajou.ac.kr

82-31-219-6939

Min Jae Yang, MD

Role: primary

creator1999@hanmail.net

82-31-219-6939 ext. 6939

Other Identifiers

AJIRB-DEV-INT-20-035

Identifier Type: -

Identifier Source: org_study_id