UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041795
Receipt number R000047703
Scientific Title Endoscopic resection for gastric submucosal tumor
Date of disclosure of the study information 2020/09/15
Last modified on 2024/03/19 09:30:31

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Basic information

Public title

Endoscopic resection for gastric submucosal tumor

Acronym

ER for gastric SMT

Scientific Title

Endoscopic resection for gastric submucosal tumor

Scientific Title:Acronym

ER for gastric SMT

Region

Japan


Condition

Condition

gastric submucosal tumor

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of endoscopic resection for gastric submucosal tumor

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

En block resection rate by endoscopy

Key secondary outcomes

Pathological complete resection rate, endoscopic procedure complete resection rate, adverse event, procedure time, comparison of preoperative diagnosis and pathological diagnosis, overall survival at five years, and disease specific survival at five years


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 resection

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


Not applicable

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1) 11-30mm by EUS and CT
2) intraluminal type

Key exclusion criteria

1) epithelial tumor
2) ulcerative finding by endoscopy

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Noriya
Middle name
Last name Uedo

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

5418567

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

TEL

0669451181

Email

noriya.uedo@oici.jp


Public contact

Name of contact person

1st name Satoki
Middle name
Last name Shichijo

Organization

Osaka International Cancer Institute

Division name

Department of Gastrointestinal Oncology

Zip code

5418567

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

TEL

0669451181

Homepage URL


Email

7satoki@oici.jp


Sponsor or person

Institute

Osaka International Cancer Institute

Institute

Department

Personal name



Funding Source

Organization

N/A

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

Osaka International Cancer Institute

Address

3-1-69, Otemae, Chuo-ku, Osaka, Japan

Tel

0669451181

Email

rinri01@opho.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

杏林大学医学部、静岡がんセンター、神戸大学医学部附属病院 国際がん医療・研究センター、横浜市立大学附属市民総合医療センター、大阪国際がんセンター


Other administrative information

Date of disclosure of the study information

2020 Year 09 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://onlinelibrary.wiley.com/doi/10.1111/den.14717

Number of participants that the trial has enrolled

46

Results

he mean (range) endoscopic tumor size was 18.8 (11-28) mm. The tumor resection and defect closure times were 54 (22-125) min and 33 (12-186) min, respectively. A 100% ER0 was achieved in all 46 patients. The EFTR procedure was accomplished in all patients without surgical intervention. One patient had delayed perforation and was managed endoscopically. GIST accounted for 76% (n = 35) of the cases. R0, R1, and RX rates were 33 (77%), 3 (6.5%), and 7 (15%), respectively.

Results date posted

2024 Year 03 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 11 Month 01 Day

Baseline Characteristics

The endoscopic lesion size was 18.8 (11-28) mm. Most lesions (63%) were in the upper third of the stomach. All tumors were of intraluminal growth type. The indications for resection were histologically proven GIST in 27 (59%) patients, increasing size in 12 (26%), and a equal to or larger than 2 cm size in 7 (15%).

Participant flow

From October 2020 to May 2023, 56 consecutive patients were assessed for eligibility at seven facilities (Figure 1). Nine patients refused to participate in this study for following reasons: investigational nature of the treatment (n=6), non-covered by national insurance (n=2), and unwillingness to receive treatment (n=1). One patient was excluded because she received systemic steroid therapy (n=1). Consequently, a total of 46 patients with 46 gastric SMTs were enrolled.

Adverse events

One delayed perforation developed on POD1 and was swiftly managed with endoscopic intervention (Clavien-Dindo Grade IIIa). Intraprocedural hemorrhage was managed via endoscopic forceps coagulation; no case required blood transfusion.

Outcome measures

ER0 status was achieved in all 46 patients (100 % )

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2020 Year 08 Month 09 Day

Date of IRB

2020 Year 08 Month 15 Day

Anticipated trial start date

2020 Year 10 Month 01 Day

Last follow-up date

2028 Year 09 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 09 Month 15 Day

Last modified on

2024 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047703


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name