| CTRI Number |
CTRI/2023/01/049017 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare gastritis due to bile reflux in children after surgery for choledochal cyst |
|
Scientific Title of Study
|
Comparison of biliary gastritis in children with choledochalcyst hepaticoduodenostomy vs hepaticoduodenostomy:A Randomised Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VISHESH JAIN |
| Designation |
Additional Professor |
| Affiliation |
AIIMS , Delhi |
| Address |
Department of Pediatric Surgery Teaching block AIIMS
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VISHESH JAIN |
| Designation |
Additional Professor |
| Affiliation |
AIIMS , Delhi |
| Address |
Department of Pediatric Surgery Teaching block AIIMS
New Delhi
DELHI
110029
India |
| Phone |
8860080432 |
| Fax |
|
| Email |
dr.vishesh79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran M D |
| Designation |
Junior Resident Doctor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Junior Resident
Department of Pediatric surgery
AIIMS,Delhi
Ansari Nagar
Delhi
New Delhi
DELHI
110029
India |
| Phone |
9544550701 |
| Fax |
|
| Email |
tokiranmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCE , NEW DELHI |
|
|
Primary Sponsor
|
| Name |
AIIMS ,Delhi |
| Address |
AIIMS Hospital
Ansari Nagar
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kiran M D |
All India Institute Of Medical Sciences |
Department of paediatric surgery
Mother and Child Block
Ansari Nagar
New Delhi
New Delhi
DELHI |
9544550701
tokiranmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (3) ICD-10 Condition: K83||Other diseases of biliary tract, (4) ICD-10 Condition: K838||Other specified diseases of biliary tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hepaticoduodenostomy |
In this procedure,during surgery porta hepatis is anastamosed with the duodenum to maintain bile flow. Patient will be then followed up with investigations for development of any complications over 6 months time |
| Intervention |
Hepaticojejunostomy |
In this procedure,during surgery porta hepatis is anastamosed with the jejunum to maintain bile flow.Patient will be then followed up with investigations for development of any complications over 6 months time |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1)Children undergoing surgical treatment for choledochal cyst at AIIMS ,Delhi |
|
| ExclusionCriteria |
| Details |
1)Patients who are lost to follow-up during the duration of the study
2)Patients not consenting for the study
3)Patients converted to open surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of biliary gastritis in children with choledochalcyst undergoing hepaticojejunostomy or hepaticoduodonostomy |
Children will be evaluated in post op period in ward till discharge,at follow up visits at 2 weeks , 1 month, then by HIDA scan at 3 months and upper gastrointestinal endoscopy and biopsy at 6 months respectively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient will also be evaluated for:
1)duodenogastric reflux
2)cholangitis
3)post op duration of stay in ward
4)time till full feeds
5)complications like stricture, intestinal obstruction, leak |
Patients will be monitored for immediate post op complications during hospital stay.After discharge you will be called for follow up at 2 weeks, 1 month,3 month and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
16/01/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Choledochal cyst is the commonest congenital biliary anomaly leading to cystic dilatation of various ducts of biliary tree. Since its recognition, various surgical procedures have been proposed for management of choledochal cysts. Hepatico-duodenostomy was initially described and commonly performed procedure. It had advantages like more physiological drainage and easier reconstruction. However, long term studies after hepatico-duodenostomy showed high incidence of duodeno-gastric reflux and biliary gastritis.
PRIMARY OBJECTIVES Evalaution of biliary gastritis in children with choledochalcyst undergoing hepaticojejunostomy vs. hepaticoduodonostomy by upper gastrointestinal endoscopy and histopathological examination of the antral biopsy
SECONDARY OBJECTIVES i) Evaluation of symptoms of gastritis ii) Evaluation of duodenogastric reflux using HIDA scan iii) To compare episodes of cholangitis following HD and HJ iv) Duration of surgery and postoperative stay and time to full feeds v) To compare the postoperative outcomes following HD and HJ in terms of postoperative complications like stricture, intestinal obstruction, leak. |