Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Ductal Adenocarcinoma; Pancreaticoduodenectomy; Mesenteric Approach
• Intervention / Treatment: Procedure: pancreaticoduodenectomy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 354
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Seiko Hirono, M.D.,PhD; Phone Number: +81-73-441-0613; Email: seiko-h@wakayama-med.ac.jp

Study Locations

• Japan
  • Fukuoka, Japan
    • Kyusyu University
    • Contact: Masafumi Nakamura
  • Hirakata, Japan
    • Kansai Medical University
    • Contact: Masanori Kon
    • Sub-Investigator: Sohei Satoi
  • Hiroshima, Japan
    • Hiroshima University
    • Contact: Yoshiaki Murakami
  • Izumo, Japan
    • Shimane University
    • Contact: Yoshitsugu Tajima
  • Kagoshima, Japan
    • Kagoshima University
    • Contact: Kousei Maemura
  • Kashihara, Japan
    • Nara Medical University
    • Contact: Masayuki Sho
  • Kumamoto, Japan
    • Kumamoto University
    • Contact: Hideo Baba
  • Nagoya, Japan
    • Nagoya University
    • Contact: Yasuhiro Kodera
    • Sub-Investigator: Suguru Yamada
  • Osaka, Japan
    • Osaka University
    • Contact: Hidetoshi Eguchi
  • Osaka, Japan
    • Osaka Medical University
    • Contact: Ryosuke Amano
  • Otsu, Japan
    • Shiga Medical University
  • Sayama, Japan
    • Kinki University
    • Contact: Ippei Matsumoto
  • Tokyo, Japan
    • Tokyo Medical University
    • Contact: Yuichi Nagakawa
  • Toyama, Japan
    • Toyama University
    • Contact: Tsutomu Fujii
  • Wakayama, Japan, 641-8510
    • Wakayama Medical University
    • Sub-Investigator: Toshio Shimokawa, PhD
    • Principal Investigator: Hiroki Yamaue, M.D., PhD
    • Sub-Investigator: Ken-ichi Okada, M.D., PhD
    • Sub-Investigator: Manabu Kawai, M.D., PhD
    • Sub-Investigator: Seiko Hirono, M.D., PhD
    • Sub-Investigator: Motoki Miyazawa, M.D., PhD
    • Sub-Investigator: Yuji Kitahata, M.D., PhD
    • Contact: Hiroki Yamaue, M.D., PhD; Phone Number: +81-73-441-0613; Email: yamaue-h@wakayama-med.ac.jp
    • Sub-Investigator: Ryohei Kobayashi, M.D., PhD
    • Sub-Investigator: Mariko Doi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	survival from surgery to death	up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	time for operation	up to 24 months
time for resection	time for resection	up to 3 months
intraoperative blood loss	intraoperative blood loss volume	up to 3 months
blood transfusion volume	transfusion volume required during operation	up to 3 months
grade B/C pancreatic fistula rate	grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition	up to 3 months
rate of delayed gastric emptying	rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition	up to 3 months
abdominal hemorrhage rate	abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition	up to 3 months
all morbidity rate	rate of all postoperative complications	up to 3 months
mortality rate	rate of operative death	up to 3 months
diarrhea rate	rate of postoperative rate	up to 24 months
R0 rate	pathological R0 rate	up to 3 months
R1 rate	pathological R1 rate	up to 3 months
the closest length between surgical margin and cancer cell	the closest length between surgical margin and cancer cell if R0	up to 3 months
number of harvested lymph nodes	number of harvested lymph nodes	up to 3 months
number of metastatic lymph nodes	number of metastatic lymph nodes	up to 3 months
lymph node ratio	number of metastatic lymph nodes divided by number of harvested lymph nodes	up to 3 months
recurrence free survival	survival from operation date to recurrence date	up to 24 months
site of initial recurrence	site of initial recurrence	up to 24 months

Collaborators and Investigators

• Sponsor: Wakayama Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2017
• Last Update Submitted That Met QC Criteria: October 21, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No