CompletedNot Applicable

Predictors of Severity of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

India50 participantsStarted 2022-04-16

Plain-language summary

Pancreaticoduodenectomy is one of the commonly performed procedure for periampullary carcinoma/distal cholangio carcinoma/head of pancreas carcinoma. Postoperative pancreatic fistula remains the most important postoperative complication following pancreatic surgery. It's severity ranges from biochemical leak to grade C POPF which can lead to mortality. Radiological and biochemical parameters in early postoperative period predicts the severity of POPF after pancreatoduodenectomy. In this study, we will be evaluating the biochemical parameters and imaging findings as predictors of the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive patients undergoing Pancreatoduodenectomy at ILBS * Duct to mucosa pancreaticojejunostomy Exclusion Criteria: * Refused for consent * Age \< 18 yrs * Hepatopancreatoduodenectomy * Multi-visceral resection * Re-exploration before POD 5 * Pancreaticogastrostomy * Dunking type of pancreaticojejunostomy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in pancreatic parenchymal thickness at pancreaticojejunostomy site/spleno-portal confluence on postoperative day 5 predicts the severity of postoperative pancreatic fistula after pancreatoduodenectomy in early postoperative period

Timeframe: Post operative day 5

Trial details

NCT IDNCT05291923

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-03

View on ClinicalTrials.gov More Post Operative Pancreatic Fistula trials