Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03317886
• Other study ID #: 2128
• Status: Not yet recruiting
• Phase: Phase 3
• First received: October 18, 2017
• Last updated: October 21, 2017
• Start date: December 1, 2017
• Est. completion date: November 30, 2021

Study information

• Verified date: October 2017
• Source: Wakayama Medical University
• Contact: Seiko Hirono, M.D.,PhD
• Phone: +81-73-441-0613
• Email: seiko-h[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 354
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Mesenteric Approach
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms
• Pancreaticoduodenectomy

Intervention

Procedure:
• pancreaticoduodenectomy
pancreaticoduodenectomy for pancreatic ductal adenocarcinoma

Locations

Country	Name	City	State
Japan	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	Otsu
Japan	Kinki University	Sayama
Japan	Tokyo Medical University	Tokyo
Japan	Toyama University	Toyama
Japan	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	survival from surgery to death	up to 48 months
Secondary	operative time	time for operation	up to 24 months
Secondary	time for resection	time for resection	up to 3 months
Secondary	intraoperative blood loss	intraoperative blood loss volume	up to 3 months
Secondary	blood transfusion volume	transfusion volume required during operation	up to 3 months
Secondary	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
Secondary	rate of delayed gastric emptying	rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition	up to 3 months
Secondary	abdominal hemorrhage rate	abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition	up to 3 months
Secondary	all morbidity rate	rate of all postoperative complications	up to 3 months
Secondary	mortality rate	rate of operative death	up to 3 months
Secondary	diarrhea rate	rate of postoperative rate	up to 24 months
Secondary	R0 rate	pathological R0 rate	up to 3 months
Secondary	R1 rate	pathological R1 rate	up to 3 months
Secondary	the closest length between surgical margin and cancer cell	the closest length between surgical margin and cancer cell if R0	up to 3 months
Secondary	number of harvested lymph nodes	number of harvested lymph nodes	up to 3 months
Secondary	number of metastatic lymph nodes	number of metastatic lymph nodes	up to 3 months
Secondary	lymph node ratio	number of metastatic lymph nodes divided by number of harvested lymph nodes	up to 3 months
Secondary	recurrence free survival	survival from operation date to recurrence date	up to 24 months
Secondary	site of initial recurrence	site of initial recurrence	up to 24 months