UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041381
Receipt number 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 2024/02/12 13:07:27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

No longer recruiting

Date of protocol fixation

2020 Year 08 Month 10 Day

Date of IRB

2020 Year 09 Month 08 Day

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

2024 Year 02 Month 12 Day



Link to view the page

Value
https://center6.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