UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028893 |
|---|---|
| Receipt number | R000033063 |
| Scientific Title | Intralesional steroid injection after endoscopic ballon dilation for stricture after endoscopic therapy (EMR, ESD, PDT) for esophageal cancer: a randomized controlled study |
| Date of disclosure of the study information | 2017/08/30 |
| Last modified on | 2022/09/11 17:53:53 |
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Basic information
Public title
Intralesional steroid injection after endoscopic ballon dilation for stricture after endoscopic therapy (EMR, ESD, PDT) for esophageal cancer: a randomized controlled study
Acronym
Steroid injection after EBD for stricture of esophageal endoscopic therapy
Scientific Title
Intralesional steroid injection after endoscopic ballon dilation for stricture after endoscopic therapy (EMR, ESD, PDT) for esophageal cancer: a randomized controlled study
Scientific Title:Acronym
Steroid injection after EBD for stricture of esophageal endoscopic therapy
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of intralesional steroid injections after endoscopic ballon dilation for esophageal endoscopic therapy's stricture.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Period between endoscopic ballon dilation and restructure symptom
Key secondary outcomes
Improvement rate of dysphagia score,
Safety of steroid injection to lacerations after endoscopic ballon dilation for esophageal endoscopic therapys scars,
Adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Steroid injection for endoscopic ballon dilation's lacerations after endoscopic therapy's stricture
Interventions/Control_2
No injection
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Esophageal stricture after esophageal EMR, ESD, PDT. Patients have stricture symptom (Dysphagia score, more than 2)
Histologies are esophageal cancers.
Strictures are located in thoracic and abdominal esophagus.
No organ failure
More than 20 years old and less than 85 years old.
Written informed consent had been obtained
Key exclusion criteria
Strictures are derived from esophageal cancer itself and CRT's scars.
Oral steroid intake.
Ulcers after endoscopic resection
Non-correctable coagulopathy, or were undergoing anticoagulant therapy
Uncontrolled complic
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka International Cancer Institute
Division name
Dept. of Gastrointestinal Oncology
Zip code
Address
3-1-69 Otemae Chuoku Osaka
TEL
+81-6-6945-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Matsuura |
Organization
Osaka International Cancer Institute
Division name
Dept. of Gastrointestinal Oncology
Zip code
Address
3-1-69 Otemae Chuoku Osaka
TEL
+81-6-6945-1181
Homepage URL
ibura9@yahoo.co.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs051180182
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs051180182
Number of participants that the trial has enrolled
18
Results
Because the number of patients enrolled in the study was lower than predicted, it was difficult to continue the study. Although the period from EBD to the appearance of dysphagia symptoms in the EBD followed by steroid group was longer than EBD group, there was no statistically significant difference. There were no adverse events associated with steroid injection.
Results date posted
| 2022 | Year | 09 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 69 years (34-83). They were all male. The stenosis was located in the upper thoracic esophagus; 9, middle thoracic esophagus; 6, lower thoracic esophagus; 3.
The Dysphasia score (DS) before dilation was DS2 in 16 patients and DS3 in 2 patients. Number of dilations before protocol treatment: less than 2 dilations in 13 patients, more than 3 dilations in 5 patients, previous radiotherapy (RT) in 8 patients, no previous RT in 10 patients, previous photodynamic therapy (PDT) in 4 patients, no previous PDT in 14 patients.
Participant flow
The number of eligible cases was lower than predicted. The study was terminated due to the limited pace of accumulation, which was 4-7 cases per year, although we had predicted an accumulation of 20 cases per year.
Adverse events
None
Outcome measures
Fifteen patients (6 in the EBD followed by steroid group and 9 in the EBD alone group) were included in the analysis. The primary endpoint of esophageal patency (the period from EBD to the appearance of dysphagia symptoms) was assessed by the log-rank test. The median period from EBD to the appearance of dysphagia symptoms in the EBD followed by steroid group was 48.5 (14-180) days, while median period from EBD to the appearance of dysphagia symptoms in the EBD group was 23 (3-180) days. Log-rank tests showed no statistically sig nificant difference between the two groups (p=0.51). After completion of the protocol treatment, DS improved in 2/6 (33.3%) of EBD followed by steroid group and 2/9 (22.2%) of the EBD group, but the difference was not statistically significant. There were no adverse events associated with steroid injection.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 08 | 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
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033063
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