| CTRI Number |
CTRI/2025/08/093520 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Delayed gastric emptying in antecolic versus retrocolic gastrojejunostomy after pancreaticoduodenectomy |
|
Scientific Title of Study
|
Delayed gastric emptying in antecolic versus retrocolic gastrojejunostomy after pancreaticoduodenectomy:a randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Mohmad Waleed |
| Designation |
Junior resident |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Department of General Surgery,5TH level B block,Post Graduate Institute of Medical Education And Research
Chandigarh
160012
India
Room 267,O block New Doctors Hostel,Post Graduate Institute Of Medical Education And Research
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9680196156 |
| Fax |
|
| Email |
syedwaleed98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Satish SN |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute Of Medical Education And Research |
| Address |
Department of General Surgery,5TH Level B block Post Graduate Institute Of Medical Education and Research
Chandigarh
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9790674694 |
| Fax |
|
| Email |
drsnsatish06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Mohmad Waleed |
| Designation |
Junior resident |
| Affiliation |
Psot Graduate Institute Of Medical Education and Research |
| Address |
Department of General Surgery, 5TH Level B Block Nehru Hospital,Post Graduate Institute of Medical Education and Research
Chandigarh
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9680196156 |
| Fax |
|
| Email |
syedwaleed98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute Of Medical Education And Research,sector 12 Pincode 160012,Chandigarh, India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute Of Medical Education And Research |
| Address |
Post Graduate Institute Of Medical Education And Research, Sector 12 Pincode 160012,Chandigarh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SYED MOHMAD WALEED |
Post Graduate Institute Of Medical Education And Research |
Department Of General Surgery, 5th Floor B block
Chandigarh
CHANDIGARH |
9680196156
syedwaleed98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (2) ICD-10 Condition: K86||Other diseases of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
antecolic or retrocolic
gastrojejunostomy after pancreaticoduodenectomy would be performed intraoperatively. |
Patients will be randomized intraoperatively after resection of specimen based on computer
generated randomized model or closed envelope technique.
-Randomized patients will be included under (Group A-Antecolic and Group B-Retrocolic)
according to the randomization
-Gastrojejunostomy(GJ) will be performed after pancreaticojejunostomy and hepaticojejunostomy.GJ loop will be taken 50 cm from HJ.The total duration of study shall be 18 months
-Group A:Antecolic-GJ loop is not passed into the transverse mesocolon and instead passed
anterior to the transverse colon and a GJ will be performed(hand sewn/stapled, side to
side/Hofmeister technique)
-Group B:Retrocolic-GJ loop passed through the transverse mesocolon and posterior to the
transverse colon and gastrojejunostomy will be performed(hand sewn/stapled, side to side/Hofmeister
technique) |
| Comparator Agent |
delayed gastric emptying(DGE) will be comapared between the group A(antecolic) and B(retrocolic) |
All the patients who underwent pancreaticoduodenectomy will be monitored for delayed gastric emptying according to the ISGPS
guidelines and graded into Grade A/B/C
Patients will be followed up till the time of dicharge and once their DGE gets settled. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective Whipple pancreaticoduodenectomy (open/laparoscopic, stapled/hand sewn and side to side/Hofmeister gastrojejunostomy)for benign and malignant aetiology.
2.Age group of 18-80 years.
3.Either gender.
4.Patients willing to give consent for being a participant in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients undergoing total pancreatectomy, distal pancreatectomy, , enucleation.
2.Patients not willing to give consent for being a participant in the study.
3.Patients undergoing PD for traumatic pancreatic injuries.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare delayed gastric emptying in antecolic vs retrocolic gastrojejunostomy after pancreaticoduodenectomy |
till the patient is discharged |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the other risk factors for delayed gastric emptying
after pancreaticoduodenectomy. |
till the patient is discharged |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/09/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To study the incidence of delayed gastric emptying in antecolic versus retrocolic gastrojejunostomy after pancreaticoduodenectomy:a randomized control trial. |