Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

NCT03317886 | Unknown Phase 3 DMC

• 1 other identifier: 2128
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 15

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreaticoduodenectomy; Mesenteric Approach

Outcome Measures

Primary Outcomes (1)

• overall survival

  survival from surgery to death

  up to 48 months

Secondary Outcomes (18)

• operative time

  up to 24 months

• time for resection

  up to 3 months

• intraoperative blood loss

  up to 3 months

• blood transfusion volume

  up to 3 months

• grade B/C pancreatic fistula rate

  up to 3 months

Study Arms (2)

mesenteric approach

ACTIVE COMPARATOR

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

Procedure: pancreaticoduodenectomy

conventional approach

ACTIVE COMPARATOR

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

Procedure: pancreaticoduodenectomy

Interventions

pancreaticoduodenectomy PROCEDURE

pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

conventional approach; mesenteric approach

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma.
• Patients whose Eastern Cooperative Oncology Group performance status are 0 or 1.
• Patients who are 20 years or older.
• Patients who have adequate organ function.
• Patients who understand sufficiently the study to provide written informed consent

You may not qualify if:

• Patients who have severe ischemic cardiovascular disease
• Patients who have liver cirrhosis or active hepatitis
• Patients who need oxygen due to interstitial pneumonia or lung fibrosis
• Patients who receive dialysis due to chronic renal failure
• Patients who need surrounding organ resection
• Patients who need artery reconstruction
• Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging
• Patients who have active multiple cancer that is thought to influence the occurrence of adverse events
• Patients who take steroid for the long period that is thought to influence the occurrence of adverse events
• Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy
• Patients who cannot understand ths study due to psychotic disease or psychological symptoms
• Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma
• Patients who underwent gastrectomy or colon/ rectum resection previously
• Patients who have severe drug allergy to iodine and gadolinium

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (15)

Kyusyu University

Fukuoka, Japan

Location

Kansai Medical University

Hirakata, Japan

Location

Hiroshima University

Hiroshima, Japan

Location

Shimane University

Izumo, Japan

Location

Kagoshima University

Kagoshima, Japan

Location

Nara Medical University

Kashihara, Japan

Location

Kumamoto University

Kumamoto, Japan

Location

Nagoya University

Nagoya, Japan

Location

Osaka Medical University

Osaka, Japan

Location

Osaka University

Osaka, Japan

Location

Shiga Medical University

Ōtsu, Japan

Location

Kinki University

Sayama, Japan

Location

Tokyo Medical University

Tokyo, Japan

Location

Toyama University

Toyama, Japan

Location

Wakayama Medical University

Wakayama, 641-8510, Japan

Location

Related Publications (2)

• 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.

  PMID: 40772617 DERIVED

• 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.

  PMID: 30409152 DERIVED

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Seiko Hirono, M.D.,PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: December 1, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: October 24, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (15)