CompletedNot Applicable

Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy

Belgium210 participantsStarted 2016-03

Plain-language summary

This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery after surgery (ERAS) program with early enteral nutrition (EEN).

Who can participate

Age range

18 Years – 85 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: * Patients, male or female, who undergo MIP + sPG for a pancreatic or peri-ampullary tumor * Patients with and without pre-operative biliary drainage (for obstructive jaundice) * Patients fit for minimally invasive pancreaticoduodenectomy (MIP) * Informed consent signed Exclusion Criteria: * Pregnancy * MIP for pancreatic trauma * MIP for complications of endoscopic retrograde cholangio-pancreaticography (ERCP) * Reconstruction of the portal vein or superior mesenteric vein * Any arterial reconstruction at the time of surgery

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

The incidence of severe complications

Timeframe: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 months

Trial details

NCT IDNCT02671357

SponsorUniversity Hospital, Gasthuisberg

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Pancreatic Neoplasms; Periampullary Neoplasms trials