• Mesopancreatic Excision for Pancreatic Duct Adenocarcinoma.

  NCT07148830

  RecruitingInterventionalNot ApplicableUpdated Aug 29, 2025
• Pancreatoduodenectomy With Mesopancreas Dissection.A Prospective Study Comparing Artery-first Approach Versus Standard Approach

  NCT03224832

  Unknown statusInterventionalNot ApplicableUpdated Aug 10, 2017
• Pancreatoduodenectomy in Pancreatic and Periampullary Tumors

  NCT02803814

  CompletedInterventionalNot ApplicableUpdated Jul 22, 2020
• Mesopancreas Study in Pancreatic Cancer

  NCT05895214

  Not yet recruitingObservationalUpdated Jun 8, 2023
• Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

  NCT07547033

  Not yet recruitingInterventionalNot ApplicableUpdated Apr 23, 2026
• Pancreas-sparing Duodenectomy Versus Pancreatoduodenectomy for Early-stage Periampullary Carcinoma

  NCT01291927

  Unknown statusInterventionalNot ApplicableUpdated Feb 9, 2011

ClinicalTrials.gov ID

NCT03317886

Lead Sponsor

Wakayama Medical UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

354Estimated

Last Update Posted

Oct 24, 2017Actual

Start Date

Dec 1, 2017Estimated

Primary Completion Date

Nov 30, 2021Estimated

Completion Date

Nov 30, 2021Estimated

Official Title

Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)

Brief Summary

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.

Detailed Description

Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.

• Pancreatic Ductal Adenocarcinoma
• Pancreaticoduodenectomy
• Mesenteric Approach

• pancreaticoduodenectomy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Wakayama Medical UniversityOTHER

yamaue-h@wakayama-med.ac.jp+81-73-441-0613