Application of Endoscopic Scissors Cutting Endoscopic Nasobiliary Drainage Tube in the Treatment of Malignant Hilar Biliary Strictures: a Multicenter, Prospective, Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Changhai Hospital
- Locations
- 1
- Primary Endpoint
- occurrence of acute cholangitis
Study Overview
Brief Summary
The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
Detailed Description
The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients age over 18 and able to tolerate ERCP.
- •Pathologically confirmed inoperable malignant hilar biliary strictures of Bismuth type II to IV.
- •No history of biliary tract surgery and first attempt at endoscopic or percutaneous drainage.
- •No acute cholangitis before ERCP.
- •Informed consent.
Exclusion Criteria
- •The patient is very ill(Septic shock, sepsis,coagulation disorders and so on) and cannot tolerate endoscopic treatment.
- •Previous biliary drainage procedure.
- •Inability to provide informed consent.
- •Participating in other clinical trials.
Outcomes
Primary Outcomes
occurrence of acute cholangitis
Time Frame: 30 days
Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).
Secondary Outcomes
- Clinical success(30 days)
- Re-intervention(6 months)
Investigators
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital