Clinical trial · Interventional
Outcomes After Laparoscopic Versus Open Pancreaticoduodenectomy
Open Versus Laparoscopic Pancreaticoduodenectomy: A Randomized Controlled Trial
NCT07328607CI-TRIAL-00101230recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Carcinoma | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Distal Cholangiocarcinoma | Distal Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Duodenal Adenocarcinoma | Duodenal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| Open Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open Pancreaticoduodenectomy (OPD)
- description
- Patients randomized to receive standard open pancreaticoduodenectomy through a bilateral subcostal incision.
- interventionNames
- Procedure: Open Pancreaticoduodenectomy
- type
- EXPERIMENTAL
- label
- Laparoscopic Pancreaticoduodenectomy (LPD)
- description
- Patients randomized to receive total laparoscopic pancreaticoduodenectomy using a standardized six-port technique.
- interventionNames
- Procedure: Laparoscopic Pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Overall Morbidity (Clavien-Dindo Classification)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 .
References
Publications (2)
- RESULTAdam 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
- RESULTPoves 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