Clinical trial NCT04600063: Isolation Procedure vs. Conventional Procedure During Distal Pancreatectosplenectomy for Pancreatic Cancer
Official title: Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resectable Pancreatic Body/Tail Carcinoma
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 2-year recurrence-free survival
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe University
state: Hyogo
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Sayama
country: Japan
facility: Kinki University
state: Osaka
city: Suita
country: Japan
facility: Osaka University
state: Osaka
city: Ōtsu
country: Japan
facility: Shiga Medical University
state: Shiga
city: Kumamoto
country: Japan
facility: Kumamoto University
city: Osaka
country: Japan
facility: Osaka City University
city: Tokyo
country: Japan
facility: Jikei University
city: Toyama
country: Japan
facility: Toyama University
city: Wakayama
country: Japan
facility: Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
Study officials:
References:
citation: Okada KI, Kawai M, Hirono S, Sho M, Tani M, Matsumoto I, Yamada S, Amano R, Toyama H, Yamashita YI, Gocho T, Shibuya K, Nagai M, Maehira H, Kamei K, Ohira G, Shirai Y, Takami H, Kimura N, Fukumoto T, Baba H, Kodera Y, Nakao A, Shimokawa T, Katsuda M, Yamaue H. ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial. Trials. 2021 Sep 16;22(1):633. doi: 10.1186/s13063-021-05523-y.