Minimally Invasive Versus Open Pancreaticoduodenectomy for Cancer: Practice Patterns and Short-term Outcomes Among 7061 Patients.
Mohamed Abdelgadir Adam, Kingshuk Choudhury, Michaela A Dinan...
https://pubmed.ncbi.nlm.nih.gov/26158612Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07328607
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
Led by Minia University · Updated on 2026-01-21
90
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of laparoscopic pancreaticoduodenectomy (LPD) compared to the traditional open pancreaticoduodenectomy (OPD) in adults with pancreatic or periampullary lesions. This prospective, randomized controlled trial aims to determine the morbimortality differences between these two surgical approaches, focusing on outcomes in patients with pancreatic ductal adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma, and pancreatic neuroendocrine tumors. In this study, 90 eligible patients will be randomly assigned to receive either the standard open pancreaticoduodenectomy through a bilateral subcostal incision or the total laparoscopic pancreaticoduodenectomy using a standardized six-port technique. The laparoscopic procedure involves a minimally invasive Whipple operation with six trocars and specimen extraction via a Pfannenstiel incision. Both approaches include lymphadenectomy and reconstruction. The study follows CONSORT guidelines and uses a prospectively maintained database. Participants will be monitored for overall morbidity using the Clavien-Dindo Classification at 90 days after surgery as the primary outcome. Secondary outcomes include lymph node harvest, resection margin status, operative time, blood loss, length of hospital stay, and readmissions. Assessments occur intraoperatively and postoperatively up to 90 days. The trial ensures careful evaluation of recovery and oncologic results in adult patients aged 18 to 75 years with resectable disease.
CONDITIONS
Brief Title
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed or clinically suspected pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma, pancreatic neuroendocrine tumors, or intraductal papillary mucinous neoplasm (IPMN)
- Resectable disease based on preoperative imaging
- ECOG performance status of 0 to 2
- ASA classification I to III
- Ability to provide informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 14 days
Participants undergo either laparoscopic or open pancreaticoduodenectomy followed by immediate postoperative care to monitor recovery and complications.
Hospital stay including surgery day and daily postoperative assessments
Post-operative Follow-up
Duration - Up to 90 days postoperatively
Participants are monitored for recovery, complications, and oncologic outcomes through follow-up visits after surgery.
Approximately 3 visits including assessments at 14 days and 90 days postoperative
Trial Site Locations
Total: 1 location
1
Liver and GIT hospital , Minia University
Minya, Minya Governorate, Egypt, 61519
Actively Recruiting
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Research Team
S
Saleh K Saleh, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Comparison of Perioperative Outcomes Between Laparoscopic and Open Approach for Pancreatoduodenectomy: The PADULAP Randomized Controlled Trial.
Ignasi Poves, Fernando Burdío, Olga Morató...
https://pubmed.ncbi.nlm.nih.gov/30138162