Isolation procedure vs. conventional procedure during distal pancreatectosplenectomy for pancreatic cancer
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-UMIN000041381
- Lead Sponsor
- Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
1) Patients who have not been diagnosed with resectable pancreatic cancer by image diagnosis at the initial diagnosis 2) Cases suspected of portal vein (superior mesenteric vein) invasion 3) Patients with severe ischemic heart disease 4) Patients with cirrhosis or active hepatitis requiring treatment 5) Patients with dyspnea requiring oxygen administration 6) Patients undergoing dialysis due to chronic renal failure 7) Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary 8) Patients with strong suspected paraaortic lymph node metastasis 9) Active double cancer thought to affect adverse events and prognosis 10) Long-term oral steroids that may affect adverse events 11) Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms. 12) Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive pancreatic ductal carcinoma is classified into four types, adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma, in accordance with the 7th edition of the regulations for handling pancreatic cancer, and invasive intraductal papillary mucinous carcinoma (IPMC) is excluded. (However, preoperative biopsy is not mandatory.) 13) Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy 14) Cases where the prescribed procedure is difficult due to history of upper abdominal surgery such as stomach, spleen, kidney, liver, transverse colon, retroperitoneum including pancreas and pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year recurrence-free survival
- Secondary Outcome Measures
Name Time Method Surgical data: Surgery time, blood loss, blood transfusion Postoperative complications: Incidence of each Grade of pancreatic fistula, Incidence of delayed gastric excretion (DGE) Grade B/C, Incidence of intraperitoneal hemorrhage (PPH) Grade B/C, Incidence of all postoperative complications, Surgical death Proportion Pathological diagnosis: ratio of tumor residual rate (R0, R1 rate), total number of resected lymph nodes, number of metastatic lymph nodes, lymph node ratio (number of metastatic lymph nodes/total number of resected lymph nodes) Treatment results: Overall survival, recurrence-free survival, local recurrence rate