Isolation Procedure vs. Conventional Procedure During Distal Pancreatectosplenectomy for Pancreatic Cancer (ISOP-DP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Resectable Pancreatic Body/Tail Carcinoma
• Intervention / Treatment: Procedure: Isolation procedure (RAMPS procedure); Procedure: Conventional procedure

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ken-ichi Okada; Phone Number: 5112 +81734410613; Email: okada@wakayama-med.ac.jp

Study Locations

• Japan
  • Kumamoto, Japan
    • Not yet recruiting
    • Kumamoto University
    • Contact: Hideo Baba
  • Osaka, Japan
    • Not yet recruiting
    • Osaka City University
    • Contact: Ryosuke Amano, M.D., PhD.
    • Sub-Investigator: Ryosuke Amano, M.D., PhD.
  • Tokyo, Japan
    • Not yet recruiting
    • Jikei University
    • Contact: Takeshi Gocho, MD, PhD; Phone Number: +81-3-3433-1111; Email: gocho@jikei.ac.jp
  • Toyama, Japan
    • Not yet recruiting
    • Toyama University
    • Contact: Tsutomu Fujii
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera
    • Contact: Ken-ichi Okada, MD; Phone Number: +81-73-441-0613; Email: okada@wakayama-med.ac.jp
    • Principal Investigator: Ken-ichi Okada, MD, PhD
  • Hyogo
    • Kobe, Hyogo, Japan
      • Not yet recruiting
      • Kobe University
      • Contact: Hirochika Toyama, M.D., PhD.
      • Sub-Investigator: Hirochika Toyama, M.D., PhD.
  • Nara
    • Kashihara, Nara, Japan
      • Not yet recruiting
      • Nara Medical University
      • Contact: Masayuki Sho, M.D., PhD.
  • Osaka
    • Sayama, Osaka, Japan
      • Not yet recruiting
      • Kinki University
      • Contact: Ippei Matsumoto, M.D., PhD
    • Suita, Osaka, Japan
      • Not yet recruiting
      • Osaka University
      • Contact: Hidetoshi Eguchi, M.D., Ph.D.
  • Shiga
    • Ōtsu, Shiga, Japan
      • Not yet recruiting
      • Shiga Medical University
      • Contact: Masaji Tani, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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).; 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.
Experimental: 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).	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).; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wakayama Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2986

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No