Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

NCT ID: NCT07328607

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-17
• Study Completion Date: 2028-04-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open Pancreaticoduodenectomy (OPD)

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

Group Type: ACTIVE_COMPARATOR

Open Pancreaticoduodenectomy

Intervention Type: PROCEDURE

Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.

Laparoscopic Pancreaticoduodenectomy (LPD)

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

Group Type: EXPERIMENTAL

Laparoscopic Pancreaticoduodenectomy

Intervention Type: PROCEDURE

Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.

Interventions

Open Pancreaticoduodenectomy

Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.

Intervention Type: PROCEDURE

Laparoscopic Pancreaticoduodenectomy

Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.

Intervention Type: PROCEDURE

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Saleh Khairy Saleh MD

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saleh K Saleh, MD

Role: PRINCIPAL_INVESTIGATOR

Minia University

Locations

Liver and GIT hospital , Minia University

Minya, Minya Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Saleh K Saleh, MD

Role: CONTACT

salehkhairy@mu.edu.eg

01201765401 ext. +2

Facility Contacts

Saleh K Saleh, MD

Role: primary

salehkhairy@mu.edu.eg

01201765401

References

Adam MA, Choudhury K, Dinan MA, Reed SD, Scheri RP, Blazer DG 3rd, Roman SA, Sosa JA. Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients. Ann Surg. 2015 Aug;262(2):372-7. doi: 10.1097/SLA.0000000000001055.

Reference Type: RESULT

PMID: 26158612 (View on PubMed)

Poves I, Burdio F, Morato O, Iglesias M, Radosevic A, Ilzarbe L, Visa L, Grande L. Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial. Ann Surg. 2018 Nov;268(5):731-739. doi: 10.1097/SLA.0000000000002893.

Reference Type: RESULT

PMID: 30138162 (View on PubMed)

Other Identifiers

1838/12/2025

Identifier Type: -

Identifier Source: org_study_id