Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy

NCT07328607 | Recruiting DMC

• 1 other identifier: 1838/12/2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Overall Morbidity (Clavien-Dindo Classification)

  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 Outcomes (5)

• Number of Lymph Nodes Retrieved

  14 days postoperative.

• Resection Margin Status (R0/R1/R2)

  14 days postoperative.

• Operative Time

  Intraoperative

• Estimated Blood Loss

  Intraoperative

• Length of Hospital Stay

  Up to 90 days.

Study Arms (2)

Open Pancreaticoduodenectomy (OPD)

ACTIVE COMPARATOR

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

Procedure: Open Pancreaticoduodenectomy

Laparoscopic Pancreaticoduodenectomy (LPD)

EXPERIMENTAL

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

Procedure: Laparoscopic Pancreaticoduodenectomy

Interventions

Open Pancreaticoduodenectomy PROCEDURE

Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique.

Open Pancreaticoduodenectomy (OPD)

Laparoscopic Pancreaticoduodenectomy PROCEDURE

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

Laparoscopic Pancreaticoduodenectomy (LPD)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Liver and GIT hospital , Minia University

Minya, Minya Governorate, 61519, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 26158612 RESULT

• 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.

  PMID: 30138162 RESULT

MeSH Terms

Conditions

Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Saleh K Saleh, MD

  Minia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saleh K Saleh, MD

CONTACT

01201765401; salehkhairy@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): April 15, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)