Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Open Pancreaticoduodenectomy, Laparoscopic Pancreaticoduodenectomy.
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma, Ampullary Carcinoma, Distal Cholangiocarcinoma, Duodenal Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
Overview
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.
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.
Interventions
- Procedure Open Pancreaticoduodenectomy
Open Pancreaticoduodenectomy with lymphadenectomy and reconstruction via open technique. - Procedure Laparoscopic Pancreaticoduodenectomy
Minimally invasive Whipple procedure using 6 trocars, with specimen extraction via Pfannenstiel incision.
Primary outcome measures
- Overall Morbidity (Clavien-Dindo Classification) [Time frame: 90 days postoperative.]
Secondary outcome measures (5)
- Number of Lymph Nodes Retrieved [Time frame: 14 days postoperative.]
- Resection Margin Status (R0/R1/R2) [Time frame: 14 days postoperative.]
- Operative Time [Time frame: Intraoperative]
- Estimated Blood Loss [Time frame: Intraoperative]
- Length of Hospital Stay [Time frame: Up to 90 days.]
Eligibility criteria
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 .
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Liver and GIT hospital , Minia University — Minya
Publications
- 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
- 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
Identifiers
NCT: NCT07328607 · 1838/12/2025