UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056325 |
|---|---|
| Receipt number | R000064291 |
| Scientific Title | A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method) |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/12/02 10:30:16 |
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Basic information
Public title
A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Acronym
A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Scientific Title
A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Scientific Title:Acronym
A Multicenter Prospective Study on Distal Pancreatectomy Using a Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Region
| Japan |
Condition
Condition
Pancreatic Diseases Requiring Distal Pancreatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify that the Pancreatic Transection Time Reduction Protocol (Three-Minute Method), which completes the pancreatic transection procedure within approximately three minutes using an automatic stapler in surgeries requiring distal pancreatectomy, does not increase the incidence of postoperative pancreatic fistula compared to the conventional method, which takes approximately 10 minutes for the transection procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence rate of Grade B/C postoperative pancreatic fistula (POPF)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Application of the Pancreatic Transection Time Reduction Protocol (Three-Minute Method)
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Indication for Distal Pancreatectomy
*Patients with diseases requiring distal pancreatectomy based on abdominal contrast-enhanced CT, regardless of the underlying condition.
*A pathological diagnosis is not mandatory.
*Variations in surgical methods, such as spleen preservation or lymphadenectomy, are acceptable.
*Prior neoadjuvant chemotherapy or radiation therapy does not exclude participation.
*The thickness of the pancreas at the planned transection site is not a limitation.
2) No Involvement of Specific Organs
*No evidence of invasion into organs other than the adrenal gland and spleen. No invasion into the portal vein.
3) No Gastrointestinal Resection
*Procedures requiring resection of the gastrointestinal tract are excluded.
4) No Prior Pancreatic Surgery
*Patients with a history of pancreatic surgery are excluded.
5) Age Requirement
*Patients aged 18 years or older on the date of obtaining consent.
6) Performance Status (PS)
*PS of 0 or 1 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
7) Laboratory Test Results
*The most recent test results within 28 days prior to registration meet the following criteria:
- Neutrophil count >= 1200/mm3
- Hemoglobin >= 9.0 g/dL
- Platelet count >= 75000/mm3
- Total bilirubin <= 2.5 mg/dL
- AST <= 150 U/L
Key exclusion criteria
1. Severe Infections
*Patients with infections requiring systemic treatment.
2. Fever
*Patients with a body temperature of >=38.0C at the time of registration.
3. Pregnancy and Related Conditions
*Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
*Men whose partners are planning to become pregnant.
4. Mental Health Conditions
*Patients with mental illness or psychiatric symptoms that interfere with daily life and are deemed unsuitable for study participation.
5. Use of Immunosuppressive Therapy
*Patients receiving continuous systemic administration of steroids or other immunosuppressive agents (oral or intravenous).
6. Severe Comorbidities
*Patients with severe complications such as:
- Heart failure: ACCF/AHA Stage C or higher.
- Renal failure: Patients undergoing maintenance dialysis.
- Liver failure: Child-Pugh classification Grade B or higher.
- Uncontrolled hypertension: Systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, even with antihypertensive medication.
- Other conditions: Hemorrhagic peptic ulcers, bowel obstruction, etc.
7. Allergy to Iodine-Based Contrast Agents
*Patients unable to use iodine-based contrast agents due to drug allergies, renal dysfunction, or bronchial asthma.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Marubashi |
Organization
Fukushima Medical University
Division name
Department of Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code
9601295
Address
1 HIkarigaoka, Fukushima city, Fukushima
TEL
024-547-1254
hbpts@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Teruhide |
| Middle name | |
| Last name | Ishigame |
Organization
Fukushima Medical University
Division name
Department of Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code
9601295
Address
1 HIkarigaoka, Fukushima city, Fukushima
TEL
024-547-1254
Homepage URL
ishigame@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University, Institutional Review Board
Address
1 HIkarigaoka, Fukushima city, Fukushima
Tel
024-547-1825
fmucrb@fmu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 02 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064291
