Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

Sponsor
Minia University
Study ID
NCT07328607
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Open Pancreaticoduodenectomy — PROCEDURE
    Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
  • Laparoscopic Pancreaticoduodenectomy — PROCEDURE
    Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.

Study Details

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.

Key Dates

Start date
Jan 17, 2026
Status verified
Jan 2026
Primary completion
Jan 15, 2028
Completion
Apr 15, 2028

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Open Pancreaticoduodenectomy (OPD)
    Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.
  • Experimental: Laparoscopic Pancreaticoduodenectomy (LPD)
    Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.

Primary Outcome Measure

Overall Morbidity (Clavien-Dindo Classification) [ Time Frame: 90 days postoperative. ]

Central Contacts

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