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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041381
Receipt No. R000047243
Scientific Title Isolation procedure vs. conventional procedure during distal pancreatectosplenectomy for pancreatic cancer
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/10

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Basic information
Public title Isolation procedure vs. conventional procedure during distal pancreatectosplenectomy for pancreatic cancer

Acronym ISOP-DP trial
Scientific Title Isolation procedure vs. conventional procedure during distal pancreatectosplenectomy for pancreatic cancer
Scientific Title:Acronym ISOP-DP trial
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1
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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 2-year recurrence-free survival
Key secondary outcomes Surgical data: Surgery time, blood loss, blood transfusion
Postoperative complications: Incidence of each Grade of pancreatic fistula, Incidence of delayed gastric excretion (DGE) Grade B/C, Incidence of intraperitoneal hemorrhage (PPH) Grade B/C, Incidence of all postoperative complications, Surgical death Proportion
Pathological diagnosis: ratio of tumor residual rate (R0, R1 rate), total number of resected lymph nodes, number of metastatic lymph nodes, lymph node ratio (number of metastatic lymph nodes/total number of resected lymph nodes)
Treatment results: Overall survival, recurrence-free survival, local recurrence rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 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.
Interventions/Control_2 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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Resectable pancreatic cancer (Adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma according to the 7th edition of the regulations for handling pancreatic cancer, excluding invasive intraductal papillary mucinous carcinoma (IPMC). However, preoperative biopsy. Is not required and allows clinical diagnosis), and a tail pancreatectomy or tail pancreatectomy is planned.
2) ASA-PS (American Society of Anesthesiology, General condition classification) is Class 1-3.
3) Age are over 20 years old.
4) He/she has sufficient judgment to understand the content of the research and has obtained written consent from the person himself/herself.
Key exclusion criteria 1) Patients who have not been diagnosed with resectable pancreatic cancer by image diagnosis at the initial diagnosis
2) Cases suspected of portal vein (superior mesenteric vein) invasion
3) Patients with severe ischemic heart disease
4) Patients with cirrhosis or active hepatitis requiring treatment
5) Patients with dyspnea requiring oxygen administration
6) Patients undergoing dialysis due to chronic renal failure
7) Cases in which arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc. is considered necessary
8) Patients with strong suspected paraaortic lymph node metastasis
9) Active double cancer thought to affect adverse events and prognosis
10) Long-term oral steroids that may affect adverse events
11) Patients who are considered to have difficulty participating in the study due to psychosis or psychiatric symptoms.
12) Cases other than invasive pancreatic ductal carcinoma by preoperative biopsy. Invasive pancreatic ductal carcinoma is classified into four types, adenocarcinoma, adenosquamous cell carcinoma, mucinous carcinoma, and anaplastic carcinoma, in accordance with the 7th edition of the regulations for handling pancreatic cancer, and invasive intraductal papillary mucinous carcinoma (IPMC) is excluded. (However, preoperative biopsy is not mandatory.)
13) Patients who cannot use both iodine drugs and gadnium drugs due to severe drug allergy
14) 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Wakayama City, Kimiidera 811-1
TEL 0734472300
Email okada@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Ken-ichi
Middle name
Last name Okada
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code 641-8510
Address Wakayama City, Kimiidera 811-1
TEL 0734472300
Homepage URL
Email okada@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Second Department of Surgery, Wakayama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Clinical Study Support Center, Wakayama Medical University Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Wakayama Medical University
Address Wakayama City, Kimiidera 811-1
Tel 0734472300
Email warinri@wakayama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 和歌山県立医科大学附属病院(和歌山県)
富山大学附属病院(富山県)
広島大学病院(広島県)
大阪大学医学部附属病院(大阪府)
大阪市立大学医学部附属病院(大阪府)
奈良県立医科大学附属病院(奈良県)
近畿大学医学部附属病院(大阪府)
名古屋大学医学部附属病院(愛知県)
熊本大学病院(熊本県)
滋賀医科大学医学部附属病院(滋賀県)
神戸大学医学部附属病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 10 Day
Last modified on
2020 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047243

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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