Total Laparoscopic vs Open Pancreaticoduodenectomy for the Treatment of Periampullary Adenocarcinomas

February 20, 2026 updated by: Mahmoud Rady, Theodor Bilharz Research Institute
Laparoscopic pancreaticoduodenectomy (LPD), a surgical option for nonpancreatic periampullary adenocarcinoma (NPPA), is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely. Our aim was to evaluate the outcomes of LPD compared with open pancreaticoduodenectomy (OPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Egypt
      • Giza, Egypt
        • Theodor Bilharz Research Institute

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:

  • • Body mass index <28.0 kg/m2.

    • Ampullary tumors, duodenal tumors restricted to the second part of the duodenum, or lower common bile duct tumors.
    • Carefully confirmed resectability of the tumors based on preoperative radiology conducted by experienced radiologists and surgeons.

Exclusion Criteria:

  • • Patients with >180 degrees superior mesenteric artery encasement

    • Any celiac abutment.
    • Unreconstructable superior mesenteric vein/portal occlusion" Aortic invasion or encasement.
    • A history of previous upper abdominal surgery.
    • Tumors extending to the uncinate.
    • Severe cardiorespiratory comorbidities.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional open pancreaticoduedectomy
15 patients underwent conventional open pancreaticoduedenctomy
Procedure: Conventional open pancreaticoduedectomy
Fifteen patients in Group A had a traditional open pancreaticoduedectomy.
Active Comparator: Total laparoscopic pancreaticoduedectomy
15 patients underwent total laparoscopic pancreaticoduedectomy
Procedure: Total laparoscopic pancreaticoduedectomy
Fifteen patients in Group A had a total laparoscopic pancreaticoduedectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery
Time Frame: in 2 years between 2023 - 2025

Laparoscopic pancreaticoduodenectomy is a complex procedure that has become increasing popular. However, there is no consensus as to whether this technique should be performed routinely.

Our aim was to evaluate the outcomes of Laparoscopic pancreaticoduodenectomy compared with open pancreaticoduodenectomy.
in 2 years between 2023 - 2025

Collaborators and Investigators

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

Sponsor

Theodor Bilharz Research Institute

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)

August 5, 2023

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

October 5, 2025

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • PT (670)

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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