Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
NCT07328607 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-01-21
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.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Ampullary Carcinoma
- Distal Cholangiocarcinoma
- Duodenal Adenocarcinoma
- Pancreatic Neuroendocrine Tumor
Interventions
- PROCEDURE
-
Open Pancreaticoduodenectomy
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
- PROCEDURE
-
Laparoscopic Pancreaticoduodenectomy
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Sponsors & Collaborators
-
Minia University
lead OTHER
Principal Investigators
-
Saleh K Saleh, MD · Minia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-17
- Primary Completion
- 2028-01-15
- Completion
- 2028-04-15
Countries
- Egypt
Study Locations
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