Total Laparoscopic vs Open Pancreaticoduodenectomy for the Treatment of Periampullary Adenocarcinomas

NCT07388082 | Completed

• 1 other identifier: PT (670)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Periampullary Carcinoma

Outcome Measures

Primary Outcomes (1)

• The incidence of pancreatic fistula after laparoscopic pancreaticoduodenectomy in comparison to open surgery

  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

Study Arms (2)

conventional open pancreaticoduedectomy

ACTIVE COMPARATOR

15 patients underwent conventional open pancreaticoduedenctomy

Procedure: Conventional open pancreaticoduedectomy

Total laparoscopic pancreaticoduedectomy

ACTIVE COMPARATOR

15 patients underwent total laparoscopic pancreaticoduedectomy

Procedure: Total laparoscopic pancreaticoduedectomy

Interventions

Total laparoscopic pancreaticoduedectomy PROCEDURE

Fifteen patients in Group A had a total laparoscopic pancreaticoduedectomy.

Total laparoscopic pancreaticoduedectomy

Conventional open pancreaticoduedectomy PROCEDURE

Fifteen patients in Group A had a traditional open pancreaticoduedectomy.

conventional open pancreaticoduedectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

Related Publications (1)

• Paniccia A, Schulick RD, Edil BH. Total Laparoscopic Pancreaticoduodenectomy: A Single-Institutional Experience. Ann Surg Oncol. 2015 Dec;22(13):4380-1. doi: 10.1245/s10434-015-4450-2. Epub 2015 Apr 18.

  PMID: 25893407 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of general surgery

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: February 4, 2026
• Study Start: August 5, 2023
• Primary Completion: August 5, 2025
• Study Completion: October 5, 2025
• Last Updated: February 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)