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A clinical trail to Check if Magnetic Devices Can Safely and Effectively Reconnect Blocked or Disconnected Bile Ducts After Gallbladder Surgery or Liver Transplant.

A Prospective Open-Label Clinical Study to Evaluate the Efficacy and Safety of Magnetic Compression Anastomosis in Patients with Biliary Stricture or Bile Duct Disconnection Following Cholecystectomy or Living Donor Liver Transplantation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093837
Enrollment
20
Registered
2025-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K831- Obstruction of bile duct

Interventions

Intervention1: Magnetic Compression Anastomosis: Once,novel minimally invasive surgical technique for creating anastomoses using magnetic force Control Intervention1: NA: NA

Sponsors

Dr Sanjay Raput
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with age between 18 to 75 - Impassable bile duct stenosis or disconnection due to Bile duct injury sustained during cholecystectomy or Living Donor Liver Transplantation - Willing to give informed consent

Exclusion criteria

Exclusion criteria: - Woman during pregnancy or lactation or anyone with mental disorder - The wall of biliary duct or jejunum was too thick (more than 3mm) so that the attractive force of magnetic device cannot meet the requirements of compression. - Anatomical variation in bile ducts system or the inner diameter is too small precluding placement of magnet - Any foreign body has been implanted in body, such as heart pacemaker. 5. - - Surgical contraindication, including, Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery. - Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. - End stage disease, complicated with biliary cirrhosis or portal hypertension. - Patients with long-term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; - Patients have the tendency or history of bleeding -Any other disease in peri operation periods (before, during, or immediately after surgery) which needs MRI examination in the next 8 weeks post operation.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with success of MCATimepoint: Day 1,Day 7, Day 30 ,Day 90,Day 180, Day 270 and Day 360

Secondary

MeasureTime frame
Time from MCA procedure to magnet removal Duration of internal catheter Average length of postoperative hospital stays Incidences of postoperative pulmonary infection and anastomotic leakage Adverse Event Monitoring Timepoint: Day 1,Day 7, Day 30 ,Day 90,Day 180, Day 270 and Day 360

Countries

India

Contacts

Public ContactDr Sanjay Rajput

Ansh Clinic

isharajput2002@gmail.com9825021923

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026