Skip to main content
MedPathMedPath Home
Clinical Trials/JPRN-jRCTs031220557
JPRN-jRCTs031220557
Recruiting
Phase 2

Steroid injection with oral administration in preventing stricture after endoscopic submucosal dissection for esophageal carcinoma. - Stellar Study

Kakushima Naomi0 sites30 target enrollmentJanuary 5, 2023
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsesophageal carcinomaesophageal strictureD000077277

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
esophageal carcinoma
Sponsor
Kakushima Naomi
Enrollment
30
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 5, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Kakushima Naomi

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients diagnosed as esophageal carcinoma.
  • •2\. Depth up to cT1b(SM1, \<200micrometers)
  • •3\. No metastasis confirmed by neck to abdominal CT.
  • •4\. Tumor with \>\=1/2 circumference or simultaneous resection of multiple adjacent lesions which are expected to have ulcer with \>3/4 circumference after ESD.
  • •5\. Patients who are indicated and scheduled for esophageal ESD.
  • •6\. ECOG performance status of 0 or1\.
  • •7\. Age \>\= 18\.
  • •8\. Patients who provide written informed consent.
  • •9\. Patients who can go to the outpatient clinic according to the clinical research schedule

Exclusion Criteria

  • •1\. Diabetes Mellitus with HbA1c \>\=8%.
  • •2\. Severe liver, renal, cardiovascular disease.
  • •3\. Patients who are receiving continuous systemic administration of steroids or other immunosuppressants at the time of informed consent
  • •4\. Patients with infectious diseases that require systemic treatment.
  • •5\. Patients who have allergy to triamcinolone, prednisolone, and sulfamethoxazole trimethoprim.
  • •6\. Patients taking desmopressin acetate.
  • •7\. Patients who have active HBV hepatitis.
  • •8\. Patients who are pregnant.
  • •9\. Patients who the investigator judges inappropriate to participate in this study.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 3
A phase III study of oral steroid administration versus local steroid injection therapy for the prevention of esophageal stricture after endoscopic submucosal dissection(JCOG1217, Steroid EESD P3)Early stage esophageal cancer after endoscopic submucosal dissection (ESD)
JPRN-UMIN000015064Japan Clinical Oncology Group (JCOG)360
Not yet recruiting
Not Applicable
A clinical study to study comparing the effect of premedication with steroids and NSAID on success of local anaesthesia of lower molars
CTRI/2022/05/042568Dr Vivek Hegde
Recruiting
Not Applicable
Intratympanic Administration Steroid by Gelatin Sponge for Ideopathic Sudden Sensorineural Hearing LossIdeopathic Sudden Sensorineural Hearing Loss (ISSHL)
JPRN-UMIN000018974Shin-ichi Kanemaru30
Completed
Not Applicable
Efficacy of oral steroids to treat the immediate symptoms of food allergyFood Allergy
JPRN-UMIN000032653Aichi Children&#39;s Health and Medical Center103
Active, not recruiting
Phase 1
Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiralrefractory strictures in patients with esophageal atresiaMedDRA version: 20.0Level: PTClassification code 10021530Term: Imperforate oesophagusSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
EUCTR2018-002863-24-FRErasmus Universitu Medical Center - Sophia Children's Hospital110