UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011690
Receipt No. R000013668
Scientific Title Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study
Date of disclosure of the study information 2013/11/01
Last modified on 2020/03/16 (Ver. 9)

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Basic information
Public title Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study
Acronym Endoscopic submucosal dissection for gastrointestinal subepithelial tumor within the submucosa
Scientific Title Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study
Scientific Title:Acronym Endoscopic submucosal dissection for gastrointestinal subepithelial tumor within the submucosa
Region
Japan

Condition
Condition gastrointestinal subepithelial tumors within submucosa
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We invetigate the efficacy, safety, and long term result of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within submucosa
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes en bloc rection rate
Key secondary outcomes complications, procedure time, emergency,emergency surgery migration rate, additional surgery rate, recurrence rate, survival observation period

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 endoscopic submucosal dissection:ESD
Interventions/Control_2
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.lesion contained within the SM layer
2.all patients whom informed consents were obtained
3. symptomatic SET strongly suspected to be a benign tumor on conventional endoscopic imaging, EUS and computed tomography
4.Tumor with the increasing tendency of tumor size greater than 1.5 times the rate before
5. confirmed histological diagnosis of carcinoid tumor; carcinoid tumor 10 mm; no lymph node or distant metastasis found
6. Granular cell tumor confirmed by preoperative tissue diagnosis
7. Indefinite SMT which is suspected malignancy in the image preoperatively
Key exclusion criteria 1.We exclude cysts, lipoma and vascular lesions with typical features in the image and asymptomatic symptoms
2.Lesions postoperative stenosis is expected, beyond the half cercumferential lumen
3.Lesions that can not check the remaining submucosa of the third layer by EUS
4.patients who do not meeting the following conditions: physical status I
to II and normal complete blood cell counts and prothrombin times are excluded

Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Kobara
Organization Faculty of Medicine, Kagawa University
Division name Gastroenterology and Neurology
Zip code 761-0793
Address Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-891-2156
Email kobara@med.kagawa-u.ac.jp

Public contact
Name of contact person
1st name Hideki
Middle name
Last name Kobara
Organization Kagawa University Hospital
Division name Gastroenterology and Neurology
Zip code 761-0793
Address Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL 087-898-5111
Homepage URL
Email kobara@med.kagawa-u.ac.jp

Sponsor
Institute Kagawa University Hospital
Institute
Department

Funding Source
Organization Kagawa University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Ehime University Hospital, Kagawa Saiseikai hospital, Kochi Medical Center, Kochi Red Cross Hospital, Shimane Prefectural Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine, Kagawa University
Address 1750-1 Ikenobe, Miki, Kita
Tel 0878985111
Email chosa@med.kagawa-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
2013 Year 11 Month 01 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications Possible
Number of participants that the trial has enrolled 57
Results 
 The rates of en bloc resection, curative resection, complications were 98.2%, 66.7%, 7.7% for overall (n=57), 100%, 61.9%, 2.4% for NET (n=42), and 93.3%, 80%, 20% for indeterminate SELs (n=15), respectively. The rates of curative resection were poor with 20% in stomach (n=5), 33% in duodenum (n=3), compared with 71% in rectum (n=24). Including conservative approach for 11 of 16 NETs who resulted in non-curative resection, no tumor recurrences occurred in all cases during follow-up period.
Results date posted
2019 Year 09 Month 16 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
57 consecutive patients (35 males, 22 females, median age: 63 years, range: 32-86 years) with GI SELs were analyzed, and were divided into definite NET (n=42) and indeterminate SELs (n=15) including one symptomatic SEL.
Participant flow 
All patients were evaluated by routine endosonography (EUS: high-frequency miniprobe, 20 MHz, UM-3R; Olympus, Tokyo, Japan) and enhanced CT. All data were extracted and compiled into a central database at Kagawa University.
Adverse events 
Complications included the incidence of any bleeding requiring an endoscopic hemostatic procedure. Perforation was defined as GI wall penetration observed during or after the procedure. Severe complication was defined as the requirement of immediate surgery repair.
Outcome measures 
The overall rates of en bloc resection, curative resection, complications, and procedure time of all 57 cases were evaluated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 08 Month 29 Day
Date of IRB
2013 Year 08 Month 29 Day
Anticipated trial start date
2013 Year 09 Month 15 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 13 Day

Other
Other related information

Management information
Registered date
2013 Year 09 Month 09 Day
Last modified on
2020 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013668