Clinical trial · Interventional
Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer
Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)
NCT03317886CI-TRIAL-00030021unknownPhase 3ClinicalTrials.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)
The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.
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 |
|---|---|---|---|
| Mesenteric Approach | — | UNRESOLVED | — |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreaticoduodenectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- mesenteric approach
- description
- mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy.
- interventionNames
- Procedure: pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- conventional approach
- description
- Conventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy.
- interventionNames
- Procedure: pancreaticoduodenectomy
Primary outcomes (1)
- measure
- overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma. 2. Patients whose Eastern Cooperative Oncology Group performance status are 0 or 1. 3. Patients who are 20 years or older. 4. Patients who have adequate organ function. 5. Patients who understand sufficiently the study to provide written informed consent Exclusion Criteria: 1. Patients who have severe ischemic cardiovascular disease 2. Patients who have liver cirrhosis or active hepatitis 3. Patients who need oxygen due to interstitial pneumonia or lung fibrosis 4. Patients who receive dialysis due to chronic renal failure 5. Patients who need surrounding organ resection 6. Patients who need artery reconstruction 7. Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging 8. Patients who have active multiple cancer that is thought to influence the occurrence of adverse events 9. Patients who take steroid for the long period that is thought to influence the occurrence of adverse events 10. Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy 11. Patients who cannot understand ths study due to psychotic disease or psychological symptoms 12. Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma 13. Patients who underwent gastrectomy or colon/ rectum resection previously 14. Patients who have severe drug allergy to iodine and gadolinium
References
Publications (2)
- DERIVEDHirono S, Kitahata Y, Motobayashi H, Satoi S, Sho M, Takami H, Kamei K, Shibuya K, Hidaka M, Uemura K, Kimura K, Mataki Y, Nagakawa Y, Hayashi H, Morimura R, Nakamura M, Wan K, Shimokawa T, Nakao A, Yamaue H; MAPLE-PD trial investigators. Mesenteric Versus Conventional Approach During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma (MAPLE-PD trial): A Multicenter Randomized Controlled Trial. Ann Surg. 2026 Apr 1;283(4):581-592. doi: 10.1097/SLA.0000000000006900. Epub 2025 Aug 7. PMID 40772617
- DERIVEDHirono S, Kawai M, Okada KI, Fujii T, Sho M, Satoi S, Amano R, Eguchi H, Mataki Y, Nakamura M, Matsumoto I, Baba H, Tani M, Kawabata Y, Nagakawa Y, Yamada S, Murakami Y, Shimokawa T, Yamaue H. MAPLE-PD trial (Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer during Pancreaticoduodenectomy): study protocol for a multicenter randomized controlled trial of 354 patients with pancreatic ductal adenocarcinoma. Trials. 2018 Nov 8;19(1):613. doi: 10.1186/s13063-018-3002-z. PMID 30409152