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Clinical Trial Record

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Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

2017-12-01

2021-11-30

2021-11-30

354

Study Overview

Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

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.

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
  • PROCEDURE: pancreaticoduodenectomy
  • 2128

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-10-18  

N/A  

2017-10-21  

2017-10-18  

N/A  

2017-10-24  

2017-10-23  

N/A  

2017-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
ACTIVE_COMPARATOR: mesenteric approach

mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy.

PROCEDURE: pancreaticoduodenectomy

  • pancreaticoduodenectomy for pancreatic ductal adenocarcinoma
ACTIVE_COMPARATOR: conventional approach

Conventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy.

PROCEDURE: pancreaticoduodenectomy

  • pancreaticoduodenectomy for pancreatic ductal adenocarcinoma
Primary Outcome MeasuresMeasure DescriptionTime Frame
overall survivalsurvival from surgery to deathup to 48 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
operative timetime for operationup to 24 months
time for resectiontime for resectionup to 3 months
intraoperative blood lossintraoperative blood loss volumeup to 3 months
blood transfusion volumetransfusion volume required during operationup to 3 months
grade B/C pancreatic fistula rategrade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definitionup to 3 months
rate of delayed gastric emptyingrate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definitionup to 3 months
abdominal hemorrhage rateabdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definitionup to 3 months
all morbidity raterate of all postoperative complicationsup to 3 months
mortality raterate of operative deathup to 3 months
diarrhea raterate of postoperative rateup to 24 months
R0 ratepathological R0 rateup to 3 months
R1 ratepathological R1 rateup to 3 months
the closest length between surgical margin and cancer cellthe closest length between surgical margin and cancer cell if R0up to 3 months
number of harvested lymph nodesnumber of harvested lymph nodesup to 3 months
number of metastatic lymph nodesnumber of metastatic lymph nodesup to 3 months
lymph node rationumber of metastatic lymph nodes divided by number of harvested lymph nodesup to 3 months
recurrence free survivalsurvival from operation date to recurrence dateup to 24 months
site of initial recurrencesite of initial recurrenceup to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Seiko Hirono, M.D.,PhD

Phone Number: +81-73-441-0613

Email: seiko-h@wakayama-med.ac.jp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Hirono 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. 2025 Aug 7. doi: 10.1097/SLA.0000000000006900. Online ahead of print.
  • Hirono 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.
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