Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

January 17, 2026 updated by: Saleh Khairy Saleh MD, Minia University

Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Minya Governorate
      • Minya, Minya Governorate, Egypt, 61519
        • Recruiting
        • Liver and GIT hospital , Minia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open Pancreaticoduodenectomy (OPD)
Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.
Procedure: Open Pancreaticoduodenectomy
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.
Experimental: Laparoscopic Pancreaticoduodenectomy (LPD)
Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.
Procedure: Laparoscopic Pancreaticoduodenectomy
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Morbidity (Clavien-Dindo Classification)
Time Frame: 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.
90 days postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Lymph Nodes Retrieved
Time Frame: 14 days postoperative.
Total count of lymph nodes harvested and examined by pathology.
14 days postoperative.
Resection Margin Status (R0/R1/R2)
Time Frame: 14 days postoperative.
Pathological assessment of margins (Pancreatic neck, bile duct, retroperitoneal, etc.) classified as R0 (>1mm), R1 (≤1mm), or R2 (macroscopic).
14 days postoperative.
Operative Time
Time Frame: Intraoperative
Time measured from skin incision to skin closure.
Intraoperative
Estimated Blood Loss
Time Frame: Intraoperative
Total blood loss recorded by the anesthesiology team.
Intraoperative
Length of Hospital Stay
Time Frame: Up to 90 days.
Total number of days from admission to discharge.
Up to 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Saleh K Saleh, MD, Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2026

Primary Completion (Estimated)

January 15, 2028

Study Completion (Estimated)

April 15, 2028

Study Registration Dates

First Submitted

December 27, 2025

First Submitted That Met QC Criteria

December 27, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1838/12/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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