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

Resectable Pancreatic Body/Tail Carcinoma Clinical Trial

— ISOP-DP  

Official title:

Randomized Controlled Phase II Study of Isolation Procedure Versus Conventional Procedure in Distal Pancreatosplenectomy for Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04600063
• Other study ID #: 2986
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: October 2020
• Source: Wakayama Medical University
• Contact: Ken-ichi Okada
• Phone: +81734410613
• Email: okada[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Resectable Pancreatic Body/Tail Carcinoma

Intervention

Procedure:
• Isolation procedure (RAMPS procedure)
In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure).
• Conventional procedure
In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed.

Locations

Country	Name	City	State
Japan	Nara Medical University	Kashihara	Nara
Japan	Kobe University	Kobe	Hyogo
Japan	Kumamoto University	Kumamoto
Japan	Osaka City University	Osaka
Japan	Shiga Medical University	Otsu	Shiga
Japan	Kinki University	Sayama	Osaka
Japan	Osaka University	Suita	Osaka
Japan	Jikei University	Tokyo
Japan	Toyama University	Toyama
Japan	Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year recurrence-free survival	Until 2 years after last entry case undergo surgery	Up to 24 months