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

Study Overview
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Brief Summary
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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.

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

Conditions
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Resectable Pancreatic Body/Tail Carcinoma

Intervention / Treatment
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* Procedure: Isolation procedure (RAMPS procedure)
* Procedure: Conventional procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Conventional procedure<br>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. | Procedure: Isolation procedure (RAMPS procedure)<br>* 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).<br>Procedure: Conventional procedure<br>* 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.<br>|
| Experimental: Isolation procedure (RAMPS procedure)<br>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). | Procedure: Isolation procedure (RAMPS procedure)<br>* 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).<br>Procedure: Conventional procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year recurrence-free survival | Until 2 years after last entry case undergo surgery | Up to 24 months |