| CTRI Number |
CTRI/2025/02/079857 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use Of Indocyanine Green To Assess Blood Supply At the Cut End Of Pancreas To Predict Pancreatic Leaks After Surgery In Patients Undergoing Pancreaticoduodenectomy |
|
Scientific Title of Study
|
Indocyanine Green Guided Fluorescence In The Pancreatic Stump In Predicting Postoperative Pancreatic Fistula In Patients Undergoing Pancreaticoduodenectomy A prospective Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJ KUMAR N |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Additional professor cabin, department of surgery, old institutional block,
JIPMER campus.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443292979 |
| Fax |
|
| Email |
raj.jipmer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AISHVARYA KANNAN |
| Designation |
Junior resident |
| Affiliation |
JIPMER |
| Address |
Department of surgery, old institutional block, JIPMER campus.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9632525840 |
| Fax |
|
| Email |
aishkane1497@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJ KUMAR N |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Additional professor cabin, department of surgery, old institutional block,
JIPMER Campus.
PONDICHERRY
605006
India |
| Phone |
9443292979 |
| Fax |
|
| Email |
raj.jipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006. |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 |
| 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 |
| Dr RAJ KUMAR N |
JIPMER |
Department of surgery, old institutional block,JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
9443292979
raj.jipmer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (HUMAN STUDIES) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C251||Malignant neoplasm of body of pancreas, (2) ICD-10 Condition: C170||Malignant neoplasm of duodenum, (3) ICD-10 Condition: K861||Other chronic pancreatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection of indocyanine green |
After pancreaticoduodenectomy, under infrared light examination, 5 mg of indocyanine green dye is injected via a peripheral intravenous access in all recruited patients |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18years of age undergoing pancreatodupdenectomy |
|
| ExclusionCriteria |
| Details |
Pregnancy, lactation, allergy to ICG, intra-operative distant metastasis, R2 resection, pancreatitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Among patients more than 18 years of age undergoing pancreaticoduodenectomy, the perfusion status of post resection pancreatic stump using ICG fluorescence, and its association with the occurrence of POPF will be studied. |
At baseline, Post operative day 0 and 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of post-pancreatectomy hemorrhage (PPH)
2.Biliary fistula
3.Clavien-Dindo score
4.Length of hospital stay.
5. 30-day mortality.
|
Day 0, Day 3, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/02/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [raj.jipmer@gmail.com].
- For how long will this data be available start date provided 13-07-2026 and end date provided 24-01-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The treatment of choice for periampullary tumors pancreaticoduodenectomy (PD).Post operative pancreatic fistulae (POPF) stands among the most common as well as challenging complications of PD, with a considerably high rate of morbidity as well as mortality. High incidence of POPF is highly likely to occur if the main pancreatic duct is left undilated, if the texture of pancreas is soft, and if blood loss> 1000ml. Reduced perfusion of the pancreatic remnant is one of the proposed reasons for POPF.Realtime perfusion of organs can be evaluated by indocyanine green (ICG) and is being used in various GI surgical procedures to reduce anastomotic leak.Data is limited with respect to intra-operative ICG based vascularity of the pancreatic stump to decrease POPF after PD.Hence this study is being done to study intra-operative use of indocyanine green (ICG) for perfusion of pancreatic stump in predicting post operative pancreatic fistula in patients undergoing pancreaticoduodenectomy. |