Two-in-one Covered and Uncovered Metal Stent

Pancreatic Cancer Clinical Trial

Official title:

Feasibility and Safety of a Newly Developed Two-in-one Covered and Uncovered Metal Stent for Inoperable Malignant Distal Biliary Obstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337333
• Other study ID #: AJIRB-DEV-INT-20-035
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Ajou University School of Medicine
• Contact: Min Jae Yang, MD, PhD
• Phone: 82-31-219-7821
• Email: creator1999[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

?Malignant biliary obstruction, 2 cm distal to the hilum ?Not eligible for curative surgical resection owing to metastasis, locally advanced stage, or high operation risk ?Eastern Cooperative Oncology Group Performance status 0-3

Exclusion Criteria:

?Being evaluated for potential benign biliary stricture or possible operation ?History of biliary surgery except cholecystectomy ?Coagulopathy (International normalized ratio >1.5, platelet count <50,000) ?Coexist other organ dysfunction (American Society of Anesthesiologist physical status grade III or IV) ?Inability to obtain informed consent

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Lymph Node Metastases
• Pancreatic Cancer

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon	Gyeong Gi Do
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall patient survival		From the date of stent insertion until the date of death from any cause, assessed upto 12 months
Secondary	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