Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy (NCT07328607) | Clinical Trial Compass
RecruitingNot Applicable
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Egypt90 participantsStarted 2026-01-17
Plain-language summary
This is a monocentric, prospective, randomized controlled trial comparing the safety and efficacy of laparoscopic pancreaticoduodenectomy (LPD) versus open pancreaticoduodenectomy (OPD). The study aims to determine the morbimortality of the laparoscopic approach compared to the gold standard open approach in adult patients with pancreatic or periampullary lesions.
Who can participate
Age range
18 Years – 75 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:
* Age ≥18 years.
* Histologically confirmed or clinically suspected lesions of: Pancreatic head adenocarcinoma, Ampullary carcinoma, Distal cholangiocarcinoma, Duodenal adenocarcinoma, Pancreatic neuroendocrine tumors, or Intraductal Papillary Mucinous Neoplasm(IPMN) .
* Resectable disease based on preoperative imaging.
* Eastern Cooperative Oncology Group(ECOG) performance status 0-2.
* American Society of Anesthesiologists(ASA )classification I-III.
* Patients able to provide informed consent.
Exclusion Criteria:
* Emergency surgery.
* Previous pancreatic surgery.
* Concurrent major abdominal procedures .
* ASA classification IV or higher.
* Metastatic disease identified preoperatively.
* Locally advanced unresectable disease.
* Active infection or sepsis at time of surgery.
* Severe cardiopulmonary comorbidities precluding major surgery.
* Pregnancy.
* Procedures requiring Total Pancreatectomy, Distal Pancreatectomy, or Enucleation .
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.
1This trial is comparing laparoscopic versus open pancreaticoduodenectomy — can you help me understand which surgical approach you would recommend for my specific diagnosis, and why?
2Since this study is primarily measuring overall morbidity using the Clavien-Dindo Classification, does that mean the main goal is to compare complication rates between the two surgical techniques rather than long-term survival, and how should that affect how I think about joining?
3This trial is listed as Phase NA, which suggests it's more of an observational or comparative effectiveness study rather than a traditional drug trial — does that mean I would still receive standard surgical care, or would there be any changes to my treatment based on being enrolled?
4Given that my diagnosis falls under one of the conditions this trial covers, like pancreatic ductal adenocarcinoma or another listed tumor type, do you think my case is typical enough that the trial's findings would likely apply to me, or are there features of my situation that make me an unusual candidate?
5Are there logistical or follow-up demands associated with participating in this outcomes study that I should plan for, such as additional visits or data collection appointments beyond what my standard surgical care would already require?
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.