Status:
UNKNOWN
Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer
Lead Sponsor:
Wakayama Medical University
Conditions:
Pancreatic Ductal Adenocarcinoma
Pancreaticoduodenectomy
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 rando...
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 int...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2021
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT03317886
Start Date
December 1 2017
End Date
November 30 2021
Last Update
October 24 2017
Active Locations (15)
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1
Kyusyu University
Fukuoka, Japan
2
Kansai Medical University
Hirakata, Japan
3
Hiroshima University
Hiroshima, Japan
4
Shimane University
Izumo, Japan