| CTRI Number |
CTRI/2025/08/093837 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Magnetic Compression] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail to Check if Magnetic Devices Can Safely and Effectively Reconnect Blocked or Disconnected Bile Ducts After Gallbladder Surgery or Liver Transplant. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-001 Version No. 1.0, dated 19 May 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Rajput |
| Designation |
Principal Investigator |
| Affiliation |
Ansh Clinic |
| Address |
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008
Ahmadabad
GUJARAT
380008
India |
| Phone |
9825021923 |
| Fax |
|
| Email |
isharajput2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Rajput |
| Designation |
Principal Investigator |
| Affiliation |
Ansh Clinic |
| Address |
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008
Ahmadabad
GUJARAT
380008
India |
| Phone |
9825021923 |
| Fax |
|
| Email |
isharajput2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Rajput |
| Designation |
Principal Investigator |
| Affiliation |
Ansh Clinic |
| Address |
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008
Ahmadabad
GUJARAT
380008
India |
| Phone |
9825021923 |
| Fax |
|
| Email |
isharajput2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sanjay Rajput
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjay Raput |
| Address |
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Rajput |
Ansh Clinic |
A-1, Jaisinghbhai Park Hirabhai Tower,
Nirant Cross Rd, near Divine Buds School,
Uttamnagar, Maninagar,
Ahmedabad, Gujarat 380008
Ahmadabad
GUJARAT |
9825021923
isharajput2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHAVIR HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K831||Obstruction of bile duct, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnetic Compression Anastomosis |
Once,novel minimally invasive surgical technique for creating anastomoses using
magnetic force |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- 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 |
|
| ExclusionCriteria |
| Details |
- 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. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with success of MCA |
Day 1,Day 7, Day 30 ,Day 90,Day 180, Day 270 and Day 360 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
Day 1,Day 7, Day 30 ,Day 90,Day 180, Day 270 and Day 360 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, single-arm, open-label clinical study evaluating the efficacy and safety of Magnetic Compression Anastomosis (MCA) in patients with biliary strictures or bile duct disconnection following cholecystectomy or living donor liver transplantation. Eligible patients will undergo MCA on Day 1 after screening and consent. Follow-up visits will occur at Day 7, Day 30, Day 90, Day 180, Day 270, and Day 360, with additional visits for magnet or catheter removal as needed. The primary endpoint is successful biliary recanalization without surgical revision. Secondary endpoints include time to magnet removal, catheter duration, hospital stay, and complication rates over 12 months |