Comparing two surgical techniques for pancreatic cancer treatment
Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer
This study is testing whether a new surgical technique for pancreatic cancer can lead to better outcomes than the traditional method for patients who can have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Wakayama Medical University Academic / other |
| Locations | 10 sites (Kobe, Hyogo and 9 other locations) |
| Trial ID | NCT04600063 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an isolation procedure versus a conventional procedure during distal pancreatectosplenectomy for patients with resectable pancreatic cancer. The isolation procedure involves the transection of splenic arteries and veins at the beginning of the surgery, while the conventional method transects the splenic vein at the end. The goal is to determine which approach yields better surgical outcomes for patients undergoing this type of cancer surgery. The study will include patients who meet specific eligibility criteria related to their cancer diagnosis and overall health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old with resectable pancreatic cancer who can provide informed consent.
Not a fit: Patients with non-resectable pancreatic cancer or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with pancreatic cancer.
How similar studies have performed: While this approach is being evaluated in this trial, similar surgical techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Kobe, Hyogo and 9 other locations
- Kobe University — Kobe, Hyogo, Japan (Not_yet_recruiting)
- Nara Medical University — Kashihara, Nara, Japan (Not_yet_recruiting)
- Kinki University — Sayama, Osaka, Japan (Not_yet_recruiting)
- Osaka University — Suita, Osaka, Japan (Not_yet_recruiting)
- Shiga Medical University — Ōtsu, Shiga, Japan (Not_yet_recruiting)
- Kumamoto University — Kumamoto, Japan (Not_yet_recruiting)
- Osaka City University — Osaka, Japan (Not_yet_recruiting)
- Jikei University — Tokyo, Japan (Not_yet_recruiting)
- Toyama University — Toyama, Japan (Not_yet_recruiting)
- Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera — Wakayama, Japan (Recruiting)
Study contacts
- Study coordinator: Ken-ichi Okada
- Email: okada@wakayama-med.ac.jp
- Phone: +81734410613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.