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.
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.
Emergency surgery.
Previous pancreatic surgery.
Concurrent major abdominal procedures .
ASA classification IV or higher.
Parallel
Open Pancreaticoduodenectomy
Procedure/SurgeryOpen Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
Laparoscopic Pancreaticoduodenectomy
Procedure/SurgeryMinimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Overall Morbidity (Clavien-Dindo Classification)
Assessment of all surgical complications graded by severity using the Clavien-Dindo Classification (Grades I-V). Major complications are defined as Grade III or higher.
Number of Lymph Nodes Retrieved
Total count of lymph nodes harvested and examined by pathology.
Resection Margin Status (R0/R1/R2)
Pathological assessment of margins (Pancreatic neck, bile duct, retroperitoneal, etc.) classified as R0 (\>1mm), R1 (≤1mm), or R2 (macroscopic).
Operative Time
Time measured from skin incision to skin closure.
Estimated Blood Loss
Total blood loss recorded by the anesthesiology team.
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