臨床研究等提出・公開システム

Japanese

Date of registration	July. 02, 2020
Last modified on	July. 31, 2024
Trial ID	jRCTs032200062

Scientific Title	EUS-guided gastrojejunostomy for malignant gastric outlet obstruction
Public Title	EUS-guided gastrojejunostomy for malignant gastric outlet obstruction

Completion date	Dec. 31, 2023
Result actual enrolment	6
Baseline Characteristics	The mean age was 67.8 years, the male to female ratio was 4:2, the primary disease was pancreatic cancer in 4 cases, gastric cancer in 1 case, and gallbladder cancer in 1 case, and the GOOSS score (Gastric Outlet Obstruction Scoring System; no oral intake 0 points, liquid only 1 point, soft solids 2 points, Low residue or full diet 3 points) was 0 in 5 cases and 1 in 1 case.
Participant flow	Two cases were enrolled in the first year of the study, four in the second year, and none in the third year. The study plan set the enrollment period at August 2023, and only 6 cases could be accumulated within this period. The reasons for not reaching the target number of 30 cases were that the procedure was not covered by insurance, so patients had to pay for their own treatment, and the number of referrals was low because of the difficulty of transferring to other hospitals due to the COVID-19 disaster. The reason for not extending the study period was that this study was positioned as a step toward conducting a clinical trial, and because a company clinical trial for this procedure began in January 2024, it was judged that there would be a bias in the accumulation of cases if two studies of the same procedure were conducted in parallel.
Adverse events	One of the six patients had fever as an adverse event. The fever was 39.4 degrees on the same day of intervention, but CT showed no fluid retention between the stomach and jejunum or spreading of inflammation, and antipyretic medication was used to improve the fever.
Outcome measures	Treatment response rate: 100% (6/6) Procedure success rate: 100% (6/6) Adverse events rate: 16.7% (1/6) Overall survival: Median survival 124 days (95% confidence interval 0-263.8) Stent patency: 100% (6/6) Stent patency period: same as overall survival Mean procedure time: 32.2 minutes
Brief summary	An interim analysis of 6 patients showed that more than 5 patients who continued in the study achieved a therapeutic response, but the target number of patients was not reached within the study period, making it difficult to assess efficacy. All patients enrolled in the study had clinical success and technical success, with only one case of adverse event (Grade 2 fever).
Date of posting of results summaries	July. 31, 2024
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	There are no plans to share processing data.
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs032200062

Contact for Scientific Queries	Name	Itoi Takao
	Affiliation	Department of Gastroenterology and Hepatology, Tokyo Medical University
	Address	6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo
	Telephone	+81-3-3342-6111
	E-mail	itoi@tokyo-med.ac.jp
Contact for Public Queries	Name	Tsuchiya Takayoshi
	Affiliation	Department of Gastroenterology and Hepatology, Tokyo Medical University
	Address	6-7-1, Nishishinjyuku, Shinjyuku-ku, Tokyo
	Telephone	+81-3-3342-6111
	E-mail	tsuchiya@tokyo-med.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 02, 2020
Actual date of first enrollment		April. 13, 2021
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with written informed consent to participate in the study Men and women over the age of 20 Patients with malignancy diagnosed histologically or clinically Patients with CT confirmed gastric or duodenal stenosis and no intervening large blood vessels or other organs with the anastomotic jejunum Patients with difficult oral intake due to malignant gastric outlet obstruction (GOOSS score 2 points or less) Patients without indication for radical surgery and surgical gastrojejunostomy Patients with sufficient function of major organs (bone marrow, liver, kidney)
	Exclusion Criteria	A case of difficult endoscopic approach A case of difficult puncture A case of large amount of ascites A case of Performance status 4 A case with uncontrolled infection A case with serious complication in other organ. A case of informed consent is not available A case which is judged by doctor as inappropriate
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Malignant gastric outlet obstruction
Intervention(s)		EUS-guided gastrojejunostomy using Hot AXIOS system for Malignant gastric outlet obstruction
Health Condition(s) Keyword		malignant gastric outlet obstruction
Intervention(s) Keyword		EUS-guided gastrojejunostomy
Health Condition(s) Code		D017219
Intervention(s) Code		D015390
Primary Outcome(s)		clinical success rate
Secondary Outcome(s)		The rate of adverse events(AE) and kinds of AE, The length of stent patency, Technical success rate, Overall survival

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board of Tokyo Medical University
Address	6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo Japan, Tokyo
Telephone	+81-3-5323-2027
E-Mail	IRB@tokyo-med.ac.jp
Approval Status	Approval
Date of approval	May. 26, 2020

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	July. 31, 2024	(this page)	Changes
5	Mar. 10, 2022	Detail	Changes
4	Oct. 14, 2021	Detail	Changes
3	June. 25, 2021	Detail	Changes
2	Oct. 12, 2020	Detail	Changes
1	July. 02, 2020	Detail

List of change history