Isolation Procedure vs. Conventional Procedure During Distal Pancreatectosplenectomy for Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Resectable Pancreatic Body/Tail Carcinoma

• Registration Number: NCT04600063
• Lead Sponsor: Wakayama Medical University

Brief Summary

In the distal pancreatectomy (including pancreatic tail resection) for invasive ductal carcinoma of the pancreas, we evaluate the usefulness of a procedure of firstly transection of splenic arteries and veins (the isolation procedure group) compared to a conventional procedure of transection of the splenic vein at the end.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study Start: 2020-10-01
• Study First Submitted: 2020-10-18
• Study First Submitted QC: 2020-10-22
• Last Update Submitted: 2020-10-22
• Study First Posted: 2020-10-23
• Last Update Posted: 2020-10-23
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer)
• ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
• Age are over 20 years old.
• Able to understand the content of the research and has obtained written consent from the person himself/herself.

Exclusion Criteria

• Non-resectable pancreatic cancer by image diagnosis at the initial diagnosis
• Cases suspected of portal vein (superior mesenteric vein) invasion
• Patients with severe ischemic heart disease
• Patients with cirrhosis or active hepatitis requiring treatment
• Patients with dyspnea requiring oxygen administration
• Patients undergoing dialysis due to chronic renal failure
• Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary
• Patients with strong suspected paraaortic lymph node metastasis
• Active double cancer thought to affect adverse events and prognosis
• Long-term oral steroids that may affect adverse events
• Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
• Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive intraductal papillary mucinous carcinoma (IPMC) is excluded.
• Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
• 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: PARALLEL

Primary Outcome Measures

Name	Time	Method
2-year recurrence-free survival	Up to 24 months	Until 2 years after last entry case undergo surgery

Trial Locations

Locations (10)

Kobe University; 🇯🇵 Kobe, Hyogo, Japan

Nara Medical University; 🇯🇵 Kashihara, Nara, Japan

Kinki University; 🇯🇵 Sayama, Osaka, Japan

Osaka University; 🇯🇵 Suita, Osaka, Japan

Shiga Medical University; 🇯🇵 Ōtsu, Shiga, Japan

Kumamoto University; 🇯🇵 Kumamoto, Japan

Osaka City University; 🇯🇵 Osaka, Japan

Jikei University; 🇯🇵 Tokyo, Japan

Toyama University; 🇯🇵 Toyama, Japan

Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera; 🇯🇵 Wakayama, Japan