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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039505
Receipt No. R000045053
Scientific Title A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia after laparoscopic gastrectomy
Date of disclosure of the study information 2020/03/05
Last modified on 2020/03/05

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Basic information
Public title A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia after laparoscopic gastrectomy
Acronym A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia after laparoscopic gastrectomy
Scientific Title A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia after laparoscopic gastrectomy
Scientific Title:Acronym A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia after laparoscopic gastrectomy
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A multicenter randomized controlled trial will evaluate the non-inferiority of the intravenous acetaminophen for postoperative analgesia to epidural anesthesia which is considered to be standard treatment, in patients undergoing laparoscopic gastrectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of patients with an NRS score of 4 or higher at 24 hours postoperatively.
Key secondary outcomes

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group: The patient is placed under epidural anesthesia during surgery, and epidural anesthesia is used for postoperative analgesia.
Interventions/Control_2 Intervention group: Wound local anesthesia is performed at the end of surgery, and intravenous acetaminophen is given as scheduled for 3 days after surgery.
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) Histologically proven adenocarcinoma
of the stomach
2) Surgically resectable tumor (cStageI-III) by laparoscopic gastrectomy
3) Age 20 > years
4) ECOG performance status 0 or 1.
5) Cases with adequately maintained organ functions and fullfilling the following conditions within 4 weeks before registration.
WBC>3000
Plt>100000
AST<100
ALT<100
Total bilrbin<2.0mg/dL
Serum creatinine<1.5mg/dL
6) Written informed consent
Key exclusion criteria 1) Patients with synchronous or metachronous malignancies.
2) Inappropriate for epidural anesthesia
3) Patients with Hugh-Jones II or higher pulmonary disease
4) Unstable angina pectoris or history of myocardial infarction within 6 months.
5) Uncontrollable hypertension.
6) Uncontrollable diabetes mellitus
7) History of hypersensitivity of acetaminophen
8) History of hypersensitivity of ropivacaine hydrochloride hydrate or lidocaine hydrochloride
9) History of hypersensitivity of aspirin-induced asthma
10) Continuous systemic steroid therapy.
11) Women during pregnancy or breast feeding.
12) Judged inappropriate by the investigators
Target sample size 140

Research contact person
Name of lead principal investigator
1st name Sachio
Middle name
Last name Fushida
Organization Kanazawa University
Division name Gastroenterologic Surgery
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Email fushida@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Jun
Middle name
Last name Kinoshita
Organization Kanazawa University
Division name Gastroenterologic Surgery
Zip code 920-8641
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2362
Homepage URL
Email junkino0416@gmail.com

Sponsor
Institute NPO Digestive Disease Support Organization (DDSO)
Institute
Department

Funding Source
Organization NPO Digestive Disease Support Organization (DDSO)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Innovative Clinical Research Center, Kanazawa University
Address 13-1 Takara-machi, Kanazawa
Tel 076-265-2000
Email hpsangak@adm.kanazawa-u.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
2020 Year 03 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 Enrolling by invitation
Date of protocol fixation
2020 Year 03 Month 15 Day
Date of IRB
2020 Year 02 Month 27 Day
Anticipated trial start date
2020 Year 02 Month 27 Day
Last follow-up date
2023 Year 04 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 02 Month 17 Day
Last modified on
2020 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045053

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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