A Prospective Randomized Study for Efficacy of Uncovered Double Bare Metallic Stent Compared to Uncovered Single Bare Metallic Stent in Malignant Biliary Obstruction

Yonsei University

Status: Completed

Conditions: Malignant Biliary Obstruction

Treatments: Procedure: metallic biliary stent insertion (double bare - S&G Biotech.); Procedure: metallic biliary stent insertion (single bare - S&G Biotech.); Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)

Study type: Interventional

Funder types: Other

Identifiers

NCT01869894

4-2013-0204

Details and patient eligibility

About

Our study is the prospective randomized study for efficacy of uncovered double bare metallic stent compared to uncovered single bare metallic stent in malignant biliary obstruction

Enrollment: 73 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients who had malignant biliary obstruction

Exclusion criteria

• The patients who had resectable biliary malignancy
• The patients who had hilar obstruction
• The patients who had duodenal obstruction
• The patients who had other malignancy which is not related to biliary obstruction
• The patients who had uncontrolled infection
• The patients who had poor performance (ECOG =3 or 4)
• The patients who were not acquired informed consent
• The patients who had technically difficult structure for ERCP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

73 participants in 3 patient groups

uncovered double bare metallic stent (S&G Biotech.)

Active Comparator group

Description:

uncovered double bare metallic stent

Treatment:

Procedure: metallic biliary stent insertion (double bare - S&G Biotech.)

uncovered single bare metallic stent (S&G Biotech.)

Active Comparator group

Description:

uncovered single bare metallic stent

Treatment:

Procedure: metallic biliary stent insertion (single bare - S&G Biotech.)

uncovered single bare metallic stent (Taewoong Medical.)

Active Comparator group

Description:

uncovered single bare metallic stent

Treatment:

Procedure: metallic biliary stent insertion (single bare - Taewoong Medical.)