UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029217 |
|---|---|
| Receipt number | R000033398 |
| Scientific Title | Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial) |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2017/09/20 19:22:33 |
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Basic information
Public title
Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Acronym
Drainage tube study at laparoscopic liver resection
Scientific Title
Prospective study about preventive drainage tube placement at laparoscopic liver resection(Randomized Controlled Trial)
Scientific Title:Acronym
Drainage tube study at laparoscopic liver resection
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with liver tumor (hepatocellular carcinoma, metastatic liver cancer, benign tumor,etc.) adapted for laparoscopic hepatectomy (excluding biliary reconstruction, combined resection of other organs (excluding gallbladder excision)), comparison of short term results (within30 days)with and without preventive internal draining.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of incidence of adverse event correlated with liver resection(bile leakage, bleeding, thoracicoabdominal fluid, intra-abdominal abscess, wound infection:more than Grade2 of Clavien-Dindo classification)
Key secondary outcomes
other adverse event, postoperative hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
control group(drainage tube placement group)
Standards of treatment content
1)The type and number of drainage tube, the place of detention are not specified, but in principle the closed type drainage tube is used.
2)Criteria for withdrawal in drainage tube placement group:If the bilirubin level of drain fluid is less than 3 times the serum level around 3 days after surgery, it will be removed on the same day or the next day, the drain fluid level is not limited. When the drainage tube placement is extended, report the cause.
3)In cases where it is judged that drainage tube placement is necessary during operation after allocation to non drainage tube placement group, it is counted as non drainage tube placement group in which an adverse event occurred.
4)Diagnosis of bile leakage defines the bilirubin level of drain fluid to be more than 3 times the serum level. Leave it to the doctor in charge of each facility about the need for reoperation and additional drainage tube placement.
5)In case of laparotomy transition, protocol treatment is discontinued.
Interventions/Control_2
intervention group(non drainage tube placement group)
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)A patient with liver tumor that is indicated for laparoscopic hepatectomy(except biliary reconstruction).
2)A patient who have obtained written consent from participants in this study.
3)PS:0-1(ECOG grade)
4)A Patient found to have the function of the main organs by clinical examination within 28 days before registration.
5)Child-Pugh classification:A or B
Key exclusion criteria
1)A patient scheduled for other organ resection(excluding gallbladder) as combined resection.
2)A Patient who left bile drainage tube(C tube etc) during operation.
3)A patient with severe complications as follows.
intestinal palsy, intestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, heart failure, renal failure, liver failure, active ulcer of the gastrointestinal tract and active varicose veins, severe psychiatric disorders and depressive state.
4)A patient who is pregnant, has a possibility of pregnancy, is breastfeeding.
5)In addition, it is judged that the examination responsible doctor or the test sharing doctor is inappropriate as the subject of this examination.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL
06-6879-3251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Noda |
Organization
Graduate School of Medicine, Osaka University
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita 565-0871 Osaka, JAPAN
TEL
06-6879-3251
Homepage URL
tnoda@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka 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
Address
Tel
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
| 2017 | Year | 09 | Month | 20 | 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
| 2017 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2017 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033398
