Here is the design of a clinical trial:

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

Included conditions:
- Resectable Pancreatic Body/Tail Carcinoma

Study Armgroups:
- {'label': 'Conventional procedure', 'type': 'OTHER', 'description': '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.', 'interventionNames': ['Procedure: Isolation procedure (RAMPS procedure)', 'Procedure: Conventional procedure']}
- {'label': 'Isolation procedure (RAMPS procedure)', 'type': 'EXPERIMENTAL', 'description': '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).', 'interventionNames': ['Procedure: Isolation procedure (RAMPS procedure)', 'Procedure: Conventional procedure']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Isolation procedure (RAMPS procedure)', 'description': '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).', 'armGroupLabels': ['Conventional procedure', 'Isolation procedure (RAMPS procedure)']}
- {'type': 'PROCEDURE', 'name': 'Conventional procedure', 'description': '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.', 'armGroupLabels': ['Conventional procedure', 'Isolation procedure (RAMPS procedure)']}

Primary Outcomes:
- {'measure': '2-year recurrence-free survival', 'description': 'Until 2 years after last entry case undergo surgery', 'timeFrame': 'Up to 24 months'}

Please estimate the sample size based on the assumption: 
80% power, approximately 10% ineligible cases.
Sample size
          Clinical trials of isolation and conventional procedures during distal pancreatectomy for pancreatic body/tail cancer have not been widely reported. A two parallel multicenter randomized selection phase II trial compared the conventional procedure with isolation procedure as a basis for a future phase III trial [18]. Its principal aim was to evaluate whether the isolation procedure has a better 2-year recurrence-free survival rate than the conventional procedure in DPS for PDAC. In an observational study, Abe et al. reported that the recurrence rate during the approximately 2-year follow-up period of the conventional procedure was 75%, whereas that of the isolation procedure was 67% [7]. In the current study, we also assume that each group will have a similar 2-year progression-free survival rate. We therefore calculated the number of patients required on the basis of a selection design so that the conventional procedure arm would select a regimen with a 2-year recurrence-free survival rate 8% higher than the expected value with 80% probability. The minimum required number of cases is 46 cases per group. Assuming that approximately 10% of ineligible cases will occur, the target number of registered cases is set to 50 per group (100 cases in total).