Clinical trial · Interventional
Modified Single-Incision Plus One-Port Versus Conventional Five-Port Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas
Modified "Single-Incision Plus One "Versus Conventional "Five-Port" Laparoscopic Pancreaticoduodenectomy for Nonpancreatic Periampullary Adenocarcinomas: Study Protocol for A Multicentre Randomised Controlled Trial
- 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 multicenter, randomized, controlled, non-inferiority trial will compare modified single-incision plus one-port laparoscopic pancreaticoduodenectomy (mSILPD+1) with conventional five-port laparoscopic pancreaticoduodenectomy (CLPD) in adults with histologically confirmed or highly suspected non-pancreatic periampullary carcinoma who are candidates for pancreaticoduodenectomy. A total of 232 participants will be randomly assigned in a 1:1 ratio. Outcome assessors who adjudicate complications and interpret imaging will be masked to treatment assignment. The primary outcomes are all-cause mortality within 90 days after surgery and overall survival at 1 year after surgery. Secondary outcomes will assess postoperative complications, surgical performance, postoperative recovery, disease-free survival, quality of life, and health-care costs.
Conditions
Conditions (3)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Laparoscopic Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Modified Single-Incision Plus One-Port Laparoscopic Pancreaticoduodenectomy
- interventionNames
- Procedure: Modified Single Incision plus one-port Laparoscopic Pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- Conventional Five-Port Laparoscopic Pancreaticoduodenectomy
- description
- Patients undergo conventional five-port laparoscopic pancreaticoduodenectomy. Standard laparoscopic technique with five abdominal trocars is adopted for pancreaticoduodenectomy and digestive tract reconstruction.
- interventionNames
- Procedure: Conventional Laparoscopic Pancreaticoduodenectomy
Primary outcomes (2)
- measure
- Overall Survival Rate at 1 Year After Surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older and younger than 75 years. * Histopathologically confirmed non-pancreatic periampullary carcinoma, or a high clinical suspicion of non-pancreatic periampullary carcinoma when preoperative pathological confirmation is unavailable. * Determined by preoperative multidisciplinary team evaluation to require pancreaticoduodenectomy. * Able to understand and comply with study procedures. * Able and willing to provide written informed consent before any study-specific screening procedure. * Expected to benefit from therapeutic pancreaticoduodenectomy according to applicable clinical guidelines. Exclusion Criteria: * Distant metastasis, including peritoneal, hepatic, distant lymph node, or other organ metastasis. * Requirement for distal, central, or total pancreatectomy, or another palliative procedure. * Preoperative American Society of Anesthesiologists physical status classification of 4 or higher. * Concurrent malignancy other than the target cancer. * Pregnancy or breastfeeding. * Severe psychiatric disorder that would interfere with study participation. * Receipt of neoadjuvant chemotherapy or radiotherapy before surgery. * Vascular invasion requiring vascular resection, as determined by the multidisciplinary team based on preoperative abdominal imaging. * Body mass index greater than 35 kg/m². * Participation in another clinical trial within the previous 3 months.
References
Publications (0)
Data not yet available