Open PancreaticoduodenectomyLaparoscopic Pancreaticoduodenectomy
Open Pancreaticoduodenectomy: Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
Laparoscopic Pancreaticoduodenectomy: Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 .
Primary outcome measure(s)
Overall Morbidity (Clavien-Dindo Classification) — 90 days postoperative. 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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