Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

Minia University

Status: Enrolling

Conditions: Distal Cholangiocarcinoma; Ampullary Carcinoma; Pancreatic Neuroendocrine Tumor; Pancreatic Ductal Adenocarcinoma; Duodenal Adenocarcinoma

Treatments: Procedure: Open Pancreaticoduodenectomy; Procedure: Laparoscopic Pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07328607

1838/12/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Open Pancreaticoduodenectomy (OPD)

Active Comparator group

Description:

Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.

Treatment:

Procedure: Open Pancreaticoduodenectomy

Laparoscopic Pancreaticoduodenectomy (LPD)

Experimental group

Description:

Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.

Treatment:

Procedure: Laparoscopic Pancreaticoduodenectomy