UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015532 |
|---|---|
| Receipt number | R000018041 |
| Scientific Title | Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms. |
| Date of disclosure of the study information | 2014/10/26 |
| Last modified on | 2016/04/12 07:27:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.
Acronym
The efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection.
Scientific Title
Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.
Scientific Title:Acronym
The efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Superficial esophageal neoplasms (either squamous cell carcinoma or basaloid carcinoma)
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
By applying "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" after esophageal endoscopic submucosal dissection, there is a high probability that the risk of post-ESD stricture as well as risks associated with "steroid injection" alone will be minimized. The objective of this study is to evaluate the efficacy and risks of combining these methods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of endoscopic balloon dilation sessions required (within 12 weeks after ESD)
Key secondary outcomes
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
Prevention
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
Application of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" after esophageal 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) Superficial esophageal neoplasm (either squamous cell carcinoma or basaloid carcinoma) is pathologically diagnosed by endoscopic biopsy.
2) The neoplasm is located in the thoracic esophagus.
3) Lymph node metastasis is ruled out through CT examination.
4) The neoplasm meets either of the 2 following criteria:
1. a single neoplasm covering over half the circumference of the esophagus
2. multiple neoplasms that will require mucosal resection of over 3/4 the circumference of the esophagus
5) There will be only a single ESD defect.
6) The patient must be above 20 years of age.
7) The performance status of the patient must be 0-2.
8) The patient's dysphagia score must be 0.
9) Blood examination results must meet the following criteria:
1.Hb>=8.0g/dL
2.Plt>=100,000/mm3
3.AST,ALT<=150
4.Cre<=2.0mg/dL
10) Followup of the patient for 12 weeks after ESD must be possible.
11) Informed consent after sufficient explanation must be obtained.
Key exclusion criteria
1) The patient has received endoscopic treatment of the upper GI tract within 30 days of entry.
2) The patient is to receive endoscopic treatment of either the stomach or duodenum in the same session.
3) The patient has plans of receiving endoscopic treatment of the upper GI tract within 12 weeks.
4) The patient has allergy to either Lugol staining, polyglycolic acid, steroids, PPIs.
5) Possibility of pregnancy
6) Neuropsychiatric symptoms which may impair comprehension of the study.
7) A history of either angina or cardiac
infarction within 3 months
8) Uncontrolled hypertension
9) Others
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Ono |
Organization
The University of Tokyo Hospital
Division name
The Department of Gastroenterology
Zip code
Address
7-3-1 Hongou, Bunkyou-ku, Tokyo
TEL
03-3815-5411
satono-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sakaguchi |
Organization
The University of Tokyo Hospital
Division name
The Department of Gastroenterology
Zip code
Address
7-3-1 Hongou, Bunkyou-ku, Tokyo
TEL
03-3815-5411
Homepage URL
sakaguchi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
published doi:10.1038/ajg.2016.60
Between December 2014 and July 2015, 15 patients were enrolled. Each underwent per-protocol treatment with an ESD defect of over 3/4 the circumference of the esophagus. Four patients were excluded from analysis due to salvage esophagectomy. The remaining 11 patients (2 total circumferential, 9 semi-circumferential) were followed for 12 weeks.
Postoperative stricture occurred in 18.2% (2/11), with a median of 0 sessions of EBD required. Postoperative stricture was successfully prevented in one case of total circumferential resection. Of the semi-circumferential cases, postoperative stricture occurred in 11.1% (1/9), with a median of 0 EBD sessions.
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 26 | Day |
Last modified on
| 2016 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018041
