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

Not Applicable

Recruiting

• Conditions: Resectable Pancreatic Body/Tail Carcinoma
• Interventions: Procedure: Isolation procedure (RAMPS procedure); Procedure: Conventional procedure

• 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

Arm && Interventions

Group	Intervention	Description
Conventional procedure	Isolation procedure (RAMPS 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.
Isolation procedure (RAMPS procedure)	Conventional 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	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.
Isolation procedure (RAMPS 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).

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

Kumamoto University; 🇯🇵 Kumamoto, Japan

Osaka City University; 🇯🇵 Osaka, Japan

Osaka University; 🇯🇵 Suita, Osaka, Japan

Jikei University; 🇯🇵 Tokyo, Japan

Toyama University; 🇯🇵 Toyama, Japan

Shiga Medical University; 🇯🇵 Ōtsu, Shiga, Japan

Kinki University; 🇯🇵 Sayama, Osaka, Japan

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