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

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

Sponsors

Lead Sponsor: Wakayama Medical University

Source 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.

Overall Status Recruiting
Start Date 2020-10-01
Completion Date 2025-09-30
Primary Completion Date 2024-09-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
2-year recurrence-free survival Up to 24 months
Enrollment 100
Condition
Intervention

Intervention Type: Procedure

Intervention 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).

Intervention Type: Procedure

Intervention 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.

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Ken-ichi Okada

Phone: +81734410613

Phone Ext.: 5112

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Kobe University | Kobe, Hyogo, Japan Not yet recruiting Hirochika Toyama, M.D., PhD. Hirochika Toyama, M.D., PhD. Sub-Investigator
Nara Medical University | Kashihara, Nara, Japan Not yet recruiting Masayuki Sho, M.D., PhD.
Kinki University | Sayama, Osaka, Japan Not yet recruiting Ippei Matsumoto, M.D., PhD
Osaka University | Suita, Osaka, Japan Not yet recruiting Hidetoshi Eguchi, M.D., Ph.D.
Shiga Medical University | Ōtsu, Shiga, Japan Not yet recruiting Masaji Tani, M.D., Ph.D.
Kumamoto University | Kumamoto, Japan Not yet recruiting Hideo Baba
Osaka City University | Osaka, Japan Not yet recruiting Ryosuke Amano, M.D., PhD. Ryosuke Amano, M.D., PhD. Sub-Investigator
Jikei University | Tokyo, Japan Not yet recruiting Takeshi Gocho, MD, PhD +81-3-3433-1111 [email protected]
Toyama University | Toyama, Japan Not yet recruiting Tsutomu Fujii
Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera | Wakayama, 641-8510, Japan Recruiting Ken-ichi Okada, MD +81-73-441-0613 [email protected] Ken-ichi Okada, MD, PhD Principal Investigator
Location Countries

Japan

Verification Date

2020-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Wakayama Medical University

Investigator Full Name: Hiroki Yamaue

Investigator Title: Director, Principal Investigator, Professor of Second Department of Surgery

Has Expanded Access No
Number Of Arms 2
Arm Group

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.

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).

Acronym ISOP-DP
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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