UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056623 |
|---|---|
| Receipt number | R000063963 |
| Scientific Title | Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial- |
| Date of disclosure of the study information | 2025/01/05 |
| Last modified on | 2025/02/19 20:13:24 |
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Basic information
Public title
Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-
Acronym
Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-
Scientific Title
Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-
Scientific Title:Acronym
Comparison of three-sided and single-sided mattress pancreaticojejunostomy in pancreatoduodenectomy -Randomized controlled trial-
Region
| Japan |
Condition
Condition
Pancreatic head tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In pancreaticojejunostomy following pancreaticoduodenectomy for soft pancreas, a randomized controlled trial will be conducted to compare a patient group using the conventional Blumgart modified technique and a patient group in which mattress sutures are added to the cranial and caudal sides of the pancreaticojejunostomy after the Blumgart modified technique (three-sided mattress suture technique), and to evaluate the safety and usefulness of the three-sided mattress suture technique by comparing the incidence of pancreatic fistula (ISGPF grade B or C).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pancreatic fistula ISGPF grade B or C
Key secondary outcomes
Surgery-related factors, incidence of postoperative complications, incidence of remnant pancreatitis, pancreatic endocrine function, pancreatic exocrine function
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 not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group A: Modified Blumgart suture method (conventional treatment group)
During pancreaticoduodenectomy, the modified Blumgart suture method is used for pancreaticojejunostomy. For anastomosis, 5-0PDS is used for pancreatic duct mucosal anastomosis, and 3-0 or 4-0 monofilament non-absorbable suture is used for pancreaticojejunal mattress anastomosis.
Interventions/Control_2
Group B: Three-sided mattress suture (test treatment group)
At the time of pancreaticoduodenectomy, the three-sided mattress suture is used as the pancreaticojejunostomy method. In addition to the conventional Blumgart modified suture, the three-sided mattress suture method adds a mattress anastomosis with 3-0 or 4-0 monofilament non-absorbable suture to the cranial and caudal sides of the pancreaticojejunostomy site
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) Patients scheduled for pancreaticoduodenectomy who have been determined to have a soft pancreas.
(2) Preoperative CT images show that the pancreatic duct diameter at the planned site of pancreatic resection is 5mm or less.
(3) ECOG Performance Status (PS) is 0-1.
(4) Age 18 years or older.
(5) Function of major organs (bone marrow, heart, liver, kidneys, lungs, etc.) is maintained.
(6) Patients have sufficient judgment to understand the content of the research, and written consent has been obtained from the individual.
Key exclusion criteria
(1) Patients with severe ischemic heart disease
(2) Patients with liver cirrhosis or active hepatitis
(3) Patients with respiratory distress requiring oxygen due to interstitial pneumonia or pulmonary fibrosis
(4) Patients undergoing dialysis due to chronic renal failure
(5) Patients requiring combined resection of surrounding organs
(6) Patients requiring arterial reconstruction of the superior mesenteric artery, common hepatic artery, celiac artery, etc.
(7) Patients with active duplicate cancers that may affect adverse events or overall survival
(8) Patients taking oral steroids for a long period that may affect adverse events
(9) Patients with insufficient decision-making ability
(10) Other subjects deemed inappropriate by the principal investigator or investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Okada |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
kokada@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Ei |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
2591193
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
TEL
0463931121
Homepage URL
ei.shigenori.h@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143 Shimokasuya, Isehara-shi, Kanagawa-ken
Tel
0463931121
tokai-rec@tokai.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
| 2025 | Year | 01 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 12 | 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
| 2025 | Year | 01 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063963
