CompletedNot Applicable

Open Versus Total Laparoscopic Pancreaticoduodenectomy

Egypt48 participantsStarted 2022-09-01

Plain-language summary

The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope. TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon. To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ). The main questions this study aims to answer are: Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ? Is TLPD lower than OPD regarding the early complications after surgery ? Researchers will compare participants receiving TLPD with participants receiving OPD regarding : The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .

Who can participate

Age range

20 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 presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy * Patients who accepted to participate in the study. Exclusion Criteria: * Patients who were deemed inoperable or irresectable tumors by preoperative investigations. * Patients with history of previous laparotomies. * Patients with complex ventral hernias.

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

Length of hospital stay

Timeframe: From the date of surgery of every participant to the date of its discharge from hospital or death whichever comes first, assessed up to 3 months .

Length of postoperative surgical ICU stay

Timeframe: From the date of admission to SICU ( surgical intensive care unit ) after surgery to the date of discharge to ward or death whichever comes first, assessed up to 3 months .

Amount of blood loss

Timeframe: From start of surgery till skin closure

Amount of intraoperative blood transfusion

Timeframe: From start of surgery of every participant till skin closure

30-day mortality

Timeframe: From the date of surgery till one month after

Operative time in minutes

Timeframe: From time of skin incision till time of skin closure

Trial details

NCT IDNCT06661135

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Pancreatic Neoplasms trials