Clinical trial NCT03317886: Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer
Official title: Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer During Pancreaticoduodenectomy (MAPLE-PD Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Ductal Adenocarcinoma
Pancreaticoduodenectomy
Mesenteric Approach
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 354
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: overall survival
timeFrame: up to 48 months
Secondary outcomes:
measure: operative time
timeFrame: up to 24 months
measure: time for resection
timeFrame: up to 3 months
measure: intraoperative blood loss
timeFrame: up to 3 months
measure: blood transfusion volume
timeFrame: up to 3 months
measure: grade B/C pancreatic fistula rate
timeFrame: up to 3 months
measure: rate of delayed gastric emptying
timeFrame: up to 3 months
measure: abdominal hemorrhage rate
timeFrame: up to 3 months
measure: all morbidity rate
timeFrame: up to 3 months
measure: mortality rate
timeFrame: up to 3 months
measure: diarrhea rate
timeFrame: up to 24 months
measure: R0 rate
timeFrame: up to 3 months
measure: R1 rate
timeFrame: up to 3 months
measure: the closest length between surgical margin and cancer cell
timeFrame: up to 3 months
measure: number of harvested lymph nodes
timeFrame: up to 3 months
measure: number of metastatic lymph nodes
timeFrame: up to 3 months
measure: lymph node ratio
timeFrame: up to 3 months
measure: recurrence free survival
timeFrame: up to 24 months
measure: site of initial recurrence
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kyusyu University
city: Hirakata
country: Japan
facility: Kansai Medical University
city: Hiroshima
country: Japan
facility: Hiroshima University
city: Izumo
country: Japan
facility: Shimane University
city: Kagoshima
country: Japan
facility: Kagoshima University
city: Kashihara
country: Japan
facility: Nara Medical University
city: Kumamoto
country: Japan
facility: Kumamoto University
city: Nagoya
country: Japan
facility: Nagoya University
city: Osaka
country: Japan
facility: Osaka Medical University
city: Osaka
country: Japan
facility: Osaka University
city: Otsu
country: Japan
facility: Shiga Medical University
city: Sayama
country: Japan
facility: Kinki University
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Toyama
country: Japan
facility: Toyama University
city: Wakayama
country: Japan
facility: Wakayama Medical University
Study officials:
References:
citation: 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.