WithdrawnNot Applicable

Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery

Belgium0Started 2012-11

Plain-language summary

The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.

Who can participate

Age range

18 Years – 80 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 PD for a pancreatic or peri-ampullary tumor * Age between 18 to 80 years * Patients with and without pre-operative biliary drainage (for obstructive jaundice) * Pre-operative radiotherapy, chemotherapy, or biological is allowed * PD for IPMN is allowed Exclusion Criteria: * Planned concomitant surgical procedures such as simultaneous colonic resection etc. * Expected/planned reconstruction of the portal vein or superior mesenteric vein * Any arterial reconstruction at the time of surgery * Age \< 18years * Pregnancy * PD for chronic pancreatitis * PD for pancreatic trauma * PD for post-ERCP complications

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

intra-operative blood loss

Timeframe: day 0 (at the end of surgery)

Trial details

NCT IDNCT01712971

SponsorBaki Topal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Surgery trials