Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

NCT ID: NCT03317886

Last Updated: 2017-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-11-30

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.

Conditions

Pancreatic Ductal Adenocarcinoma; Pancreaticoduodenectomy; Mesenteric Approach

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mesenteric approach

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

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

conventional approach

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

Group Type: ACTIVE_COMPARATOR

pancreaticoduodenectomy

Intervention Type: PROCEDURE

pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Interventions

pancreaticoduodenectomy

pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wakayama Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hiroki Yamaue

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kyusyu University

Fukuoka, , Japan

Kansai Medical University

Hirakata, , Japan

Hiroshima University

Hiroshima, , Japan

Shimane University

Izumo, , Japan

Kagoshima University

Kagoshima, , Japan

Nara Medical University

Kashihara, , Japan

Kumamoto University

Kumamoto, , Japan

Nagoya University

Nagoya, , Japan

Osaka Medical University

Osaka, , Japan

Osaka University

Osaka, , Japan

Shiga Medical University

Ōtsu, , Japan

Kinki University

Sayama, , Japan

Tokyo Medical University

Tokyo, , Japan

Toyama University

Toyama, , Japan

Wakayama Medical University

Wakayama, , Japan

Countries

Japan

Central Contacts

Seiko Hirono, M.D.,PhD

Role: CONTACT

Phone: +81-73-441-0613

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

Facility Contacts

Masafumi Nakamura

Role: primary

Masanori Kon

Role: primary

Yoshiaki Murakami

Role: primary

Yoshitsugu Tajima

Role: primary

Kousei Maemura

Role: primary

Masayuki Sho

Role: primary

Hideo Baba

Role: primary

Yasuhiro Kodera

Role: primary

Ryosuke Amano

Role: primary

Hidetoshi Eguchi

Role: primary

Ippei Matsumoto

Role: primary

Yuichi Nagakawa

Role: primary

Tsutomu Fujii

Role: primary

Hiroki Yamaue, M.D., PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40772617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30409152 (View on PubMed)

Other Identifiers

2128

Identifier Type: -

Identifier Source: org_study_id