Trials / Recruiting
RecruitingNCT07328607
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Minia University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. This study will randomize 90 eligible patients to receive either LPD or OPD. The primary objective is to compare overall morbidity using the Clavien-Dindo Classification at 90 days postoperative. Secondary objectives include assessment of oncologic outcomes (lymph node harvest, margin status), perioperative metrics (operative time, blood loss), and postoperative recovery (length of stay, readmissions). The study utilizes a prospectively maintained database and adheres to CONSORT guidelines.
Conditions
- Pancreatic Ductal Adenocarcinoma
- Ampullary Carcinoma
- Distal Cholangiocarcinoma
- Duodenal Adenocarcinoma
- Pancreatic Neuroendocrine Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2026-01-17
- Primary completion
- 2028-01-15
- Completion
- 2028-04-15
- First posted
- 2026-01-09
- Last updated
- 2026-01-21
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07328607. Inclusion in this directory is not an endorsement.