UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052588 |
|---|---|
| Receipt number | R000059631 |
| Scientific Title | A prospective study of endoscopic full-thickness resection for gastrointestinal submucosal tumors in single-center |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2025/04/25 18:10:02 |
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Basic information
Public title
endoscopic full-thickness resection for gastrointestinal submucosal tumors
Acronym
endoscopic full-thickness resection for SMT
Scientific Title
A prospective study of endoscopic full-thickness resection for gastrointestinal submucosal tumors in single-center
Scientific Title:Acronym
EFTR 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 safety and efficacy of endoscopic full-thickness resection for gastric submucosal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completion rate of EFTR and endoscopic suturing
Key secondary outcomes
en-bloc, complete resection rate for EFTR
the time required for EFTR and suturing
Intraoperative and postoperative adverse event rate
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
The study will be divided into three phases with a total of 13 patients. In all cases, EFTR will be performed by physicians who meet certain criteria and are skilled in endoscopic procedures.
Phase 1
Three cases of SMT on the anterior wall of the stomach will be performed under general anesthesia and under laparoscopic observation by the surgeon.
Stage 2
Under general anesthesia and under laparoscopic observation by the surgeon, 7 cases will be performed regardless of the site of the lesion.
Step 3
The last 3 cases are performed under general anesthesia without laparoscopic support.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility Criteria
1) Preoperative diagnosis of gastric submucosal tumor between 2 cm and 3 cm by CT and ultrasound endoscopy (EUS)
2) A gastric submucosal tumor of 2 cm or less that meets one of the following conditions
a) GIST (gastrointestinal stromal tumor) diagnosed or suspected by imaging or histological diagnosis
b) Suspected malignant findings such as ulceration, irregular margins, or tendency to enlarge.
2) Patients who can be resected by laparoscopic local excision (including LECS) at the institution
3) The line of resection does not extend to the spleen or pylorus, and there is no problem with endoscopic movement during preoperative endoscopy, and EFTR is judged to be feasible *1
4) It is judged that there is sufficient space for full-layer suture after EFTR.
5) Gastric submucosal tumor is of intraductal or intramural type.
6) No previous epigastric surgery and no previous surgery involving resection of the intestinal tract (including the stomach).
However, patients with no postoperative ileus despite a history of the following examinations and surgeries are acceptable.
(1) Laparoscopy or laparoscopic and laparoscopic (assisted) appendicectomy for appendicitis
Laparoscopic cholecystectomy for cholelithiasis
Laparoscopic and laparoscopic (assisted) resection of the sigmoid colon
4) Open and laparoscopic (assisted) resection of the rectum (without stoma)
7) Age at enrollment: 18 years or older
8) Performance status (PS) of 0-1 according to ECOG criteria
9) Patient's written consent to participate in the study
1 The three cases in the first stage are defined as lesions with tumor margins more than 3 cm away from the eruption/pylorus.
Key exclusion criteria
Exclusion Criteria
1) Gastric submucosal tumor of extrapubic origin
2) Temporary withdrawal of antiplatelet agents or anticoagulants is not possible
3) Platelet count less than 50,000/mm3 or PT-INR greater than 2 in patients not taking anticoagulants
4) Patients with liver cirrhosis that falls into the B-C category on the Child-Pugh score
5) Patients with chronic renal failure on maintenance dialysis
6) Patients whose EFTR resection line is considered to extend to the spleen or pylorus.
7) Patients whose attending physician determines that participation in this study is inappropriate.
Discontinuation Criteria
1) When it is considered necessary to proceed to laparotomy.
2) If the attending physician or surgeon determines that EFTR is not feasible prior to the start of ETFR
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | Mai |
| Middle name | |
| Last name | Makiguchi |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
1040045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
0335422511
Homepage URL
mego@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Endoscopy Division
Yutaka Saito
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
0335422511
mego@ncc.go.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
| 2023 | Year | 10 | Month | 25 | 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
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059631
