Magnetic Compression Anastomosis for Recanalization of Biliary Stricture

NCT ID: NCT04170933

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-12-31

Brief Summary

Biliary stricture is a common complication after end-to-end biliary anastomosis, especially after liver transplantation. This study is designed to investigate the safety and efficacy of magnetic recanalization technique, a newly clinical method, for treating biliary anastomotic stricture.

Detailed Description

Biliary anastomotic stricture is a common complication of after end-to-end biliary anastomosis. Magnetic recanalization is a promising way to establish connection of biliary tract after stenosis or completed obstruction. This study is designed to investigate the safety and efficacy of magnetic recanalization among patients with severe biliary stricture after biliary anastmosis. Patients who failed to undergo stent placement with endoscopic retrograde cholangiopancretography (ERCP) would be enrolled for magnetic recanalization treatment. Magnetic treatment will be implemented by several steps. Firstly, placement of one magnet through the sinus of percutaneous transhepatic cholangio drainage (PTCD) in upper part of the bile duct; Second, introduction of another magnet via ERCP into the distal part of the bile duct, and making them be mated together; Third, after necrosis of the tissue between the two magnets, the magnets will drop off and be taken out together through the thread connected with them out of the mouth. Last, a plastic stent should be placed in the bile duct for a lasting support. The time of recanalization (drop off of the magnets), and adverse events (e.g. fever, melena, nausea, vomiting, anorexia, hematemesis, abdominal pain, and gastrointestinal bleeding) will be recorded, and each patient will be followed up for long-term outcomes.

Conditions

Biliary Anastomotic Stricture; Biliary Tract Diseases; Cholestasis, Extrahepatic; Endotoxicosis

Study Design

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

Study Groups

Magnetic recanalization

The subjects in this group will be treated by magnetic recanalization

Group Type: EXPERIMENTAL

Magnetic recanalization

Intervention Type: PROCEDURE

1. Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula.

2. Perform endoscopic sphincterotomy (EST).

3. Place one magnet above the stricture through the PTCD fistula.

4. Introduce another magnet below the stricture through the common bile duct with ERCP.

5. Place the magnets at the appropriate point to attract each other.

6. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets.

7. A plastic stent will be placed in the bile duct for lasting support.

Interventions

Magnetic recanalization

1. Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula.

2. Perform endoscopic sphincterotomy (EST).

3. Place one magnet above the stricture through the PTCD fistula.

4. Introduce another magnet below the stricture through the common bile duct with ERCP.

5. Place the magnets at the appropriate point to attract each other.

6. The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets.

7. A plastic stent will be placed in the bile duct for lasting support.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1. Age ≥ 18 years old and ≤65 years old
• 2. patients with biliary stricture after end-to-end biliary anastomosis

Exclusion Criteria

• 1. Pregnant woman
• 2.Have a history of cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis or electrocardiographic abnormal Q wave (ECG)), stroke (ischemic or hemorrhagic, including transient ischemic attack)
• 3. Severe lung diseases such as COPD and asthma
• 4. Patients with acute infection or inflammation (i.e. pneumonia)
• 5. Any other medical condition considers the longest survival time to be less than 2 years
• 7. Immunodeficiency or HIV positive
• 8. No autonomy, inability to participate in follow-up
• 9. Illiterate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Lv, MD,phD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Xian JiaotongUniversity

Locations

First Affiliated Hospital of Xian JiaotongUniversity

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yi Lv, MD,phD

Role: CONTACT

luyi169@126.com

86-29-85323900

Xu-Feng Zhang, MD,phD

Role: CONTACT

xfzhang125@126.com

86-29-85323626

Facility Contacts

Yi Lv, MD，PHD

Role: primary

luyi169@126.com

0086-13991200581

Other Identifiers

XJTU1AF-CRF-2015-001-4

Identifier Type: -

Identifier Source: org_study_id