Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

Phase 3

• Conditions: Pancreatic Ductal Adenocarcinoma; Mesenteric Approach; Pancreaticoduodenectomy
• Interventions: Procedure: pancreaticoduodenectomy

• Registration Number: NCT03317886
• Lead Sponsor: Wakayama Medical University

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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-18
• Last Update Submitted: 2017-10-21
• Study First Posted: 2017-10-23
• Last Update Posted: 2017-10-24
• Study Start: 2017-12-01
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
overall survival	up to 48 months	survival from surgery to death

Secondary Outcome Measures

Name	Time	Method
operative time	up to 24 months	time for operation
time for resection	up to 3 months	time for resection
intraoperative blood loss	up to 3 months	intraoperative blood loss volume
blood transfusion volume	up to 3 months	transfusion volume required during operation
grade B/C pancreatic fistula rate	up to 3 months	grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition
rate of delayed gastric emptying	up to 3 months	rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition
abdominal hemorrhage rate	up to 3 months	abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition
all morbidity rate	up to 3 months	rate of all postoperative complications
mortality rate	up to 3 months	rate of operative death
diarrhea rate	up to 24 months	rate of postoperative rate
R0 rate	up to 3 months	pathological R0 rate
R1 rate	up to 3 months	pathological R1 rate
the closest length between surgical margin and cancer cell	up to 3 months	the closest length between surgical margin and cancer cell if R0
number of harvested lymph nodes	up to 3 months	number of harvested lymph nodes
number of metastatic lymph nodes	up to 3 months	number of metastatic lymph nodes
lymph node ratio	up to 3 months	number of metastatic lymph nodes divided by number of harvested lymph nodes
recurrence free survival	up to 24 months	survival from operation date to recurrence date
site of initial recurrence	up to 24 months	site of initial recurrence

Trial Locations

Locations (15)

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

Tokyo Medical University; 🇯🇵 Tokyo, Japan

Nagoya University; 🇯🇵 Nagoya, Japan

Osaka Medical University; 🇯🇵 Osaka, Japan

Osaka University; 🇯🇵 Osaka, Japan

Wakayama Medical University; 🇯🇵 Wakayama, Japan

Shiga Medical University; 🇯🇵 Otsu, Japan

Kinki University; 🇯🇵 Sayama, Japan

Toyama University; 🇯🇵 Toyama, Japan

Kumamoto University; 🇯🇵 Kumamoto, Japan