UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Acronym	A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Scientific Title	A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone after laparoscopic gastrectomy
Scientific Title:Acronym	A randomized controlled trial of postoperative intravenous acetaminophen v.s. thoracic epidural analgesia alone 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 local anesthesia plus intravenous acetaminophen in postoperative analgesia to epidural anesthesia which is considered to be standard treatment, in patients undergoing laparoscopic gastrectomy.
Basic objectives2	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	Non profit foundation
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	2019 Year 12 Month 21 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	Terminated
Date of protocol fixation	2019 Year 11 Month 10 Day
Date of IRB	2020 Year 01 Month 14 Day
Anticipated trial start date	2020 Year 01 Month 14 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	2019 Year 11 Month 15 Day
Last modified on	2020 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043990