Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mesenteric approach | Active Comparator | mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pancreaticoduodenectomy | Procedure | pancreaticoduodenectomy for pancreatic ductal adenocarcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | survival from surgery to death | up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | time for operation | up to 24 months |
| time for resection | time for resection | up to 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seiko Hirono, M.D.,PhD | Contact | +81-73-441-0613 | seiko-h@wakayama-med.ac.jp |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu University | Fukuoka | Japan |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40772617 | Derived | 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. 2026 Apr 1;283(4):581-592. doi: 10.1097/SLA.0000000000006900. Epub 2025 Aug 7. | |
| 30409152 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016577 | Pancreaticoduodenectomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 | 641-8510 | Japan |
|
| 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. |