Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Ductal Adenocarcinoma, Pancreaticoduodenectomy, Mesenteric Approach

Intervention / Treatment
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* Procedure: pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or borderline resectable (only portal vein invasion) pancreatic ductal adenocarcinoma. Patients whose Eastern Cooperative Oncology Group performance status are 0 or 1. Patients who are 20 years or older. Patients who have adequate organ function. Patients who understand sufficiently the study to provide written informed consent Exclusion Criteria: Patients who have severe ischemic cardiovascular disease Patients who have liver cirrhosis or active hepatitis Patients who need oxygen due to interstitial pneumonia or lung fibrosis Patients who receive dialysis due to chronic renal failure Patients who need surrounding organ resection Patients who need artery reconstruction Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging Patients who have active multiple cancer that is thought to influence the occurrence of adverse events Patients who take steroid for the long period that is thought to influence the occurrence of adverse events Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy Patients who cannot understand ths study due to psychotic disease or psychological symptoms Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma Patients who underwent gastrectomy or colon/ rectum resection previously Patients who have severe drug allergy to iodine and gadolinium

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: mesenteric approach<br>mesenteric approach starts from lymph node dissection around the superior mesenteric artery and performs Kocher's maneuver finally during pancreaticoduodenectomy. | Procedure: pancreaticoduodenectomy<br>* pancreaticoduodenectomy for pancreatic ductal adenocarcinoma<br>|
| Active Comparator: conventional approach<br>Conventional approach starts from Kocher's maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy. | Procedure: pancreaticoduodenectomy<br>* pancreaticoduodenectomy for pancreatic ductal adenocarcinoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | survival from surgery to death | up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | time for operation | up to 24 months | 
| time for resection | time for resection | up to 3 months | 
| 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 |