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Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture

Primary Purpose

Esophageal Stenosis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Local steroid - triamcinolone acetonide
Oral steroid - predonisolone
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Stenosis focused on measuring endoscopy submucosal dissection, ESD, esophageal stenosis, esophageal stricture, steroid injection, oral prednisolone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference;
  • Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT;
  • Signed informed consent form

Exclusion Criteria:

  • Presence of invasive esophageal neoplasia
  • Hepatical cirrhosis
  • Diabetes mellitus with fasting glycemia above 200mg%
  • Use of corticosteroids in the 30 days prior to ESD
  • INR> 1.5
  • Platelet count less than 50,000
  • Active gastrointestinal ulcer
  • Severe psychiatric illness
  • Glaucoma
  • History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor

Sites / Locations

  • Instituto do Câncer do Estado de São Paulo - ICESPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Local steroid-triamcinolone acetonide

Oral steroid-predonisolone

Arm Description

Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg.

(predonisolone) administration three days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered 30, 30, 25, 25, 20, 15, 10 and 5 every 7 days, totaling 8 weeks of treatment.

Outcomes

Primary Outcome Measures

Early Stenosis rate
Stenosis to the passage of the standard endoscopic (9.8 mm)
Late Stenosis rate
Stenosis to the passage of the standard endoscopic (9.8 mm)
Early resistance rate
Resistance to the passage of the standard endoscopic (9.8 mm)
Late resistance rate
Resistance to the passage of the standard endoscopic (9.8 mm)

Secondary Outcome Measures

Number of dilations to solve the stenosis
Number of endoscopic dilations (Savary or balloon)

Full Information

First Posted
January 30, 2019
Last Updated
July 30, 2020
Sponsor
Instituto do Cancer do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04498260
Brief Title
Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture
Official Title
Prospective, Randomized Trial of Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture After Endoscopic Submucosal Dissection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
March 21, 2021 (Anticipated)
Study Completion Date
June 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard. The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.
Detailed Description
Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to esophagectomy, since it is less invasive, besides presenting good clinical results. Compared with esophagectomy, patients submitted to endoscopic resection present shorter hospitalization time, lower incidence of complications and better quality of life in the long term. However, repair of esophageal ulcer, caused by endoscopic resection, which occupies three quarters or more of the circumference of the organ, can result in the formation of stenosis. In the past, there was no consensus on the use of preventive therapies for esophageal stenosis after extensive ESD. However, Oliveira et al recently demonstrated through systematic review and meta-analysis that the use of these therapies reduces the rate of stenosis (40% on average), decreased the number of dilations to resolve the stenosis (8 sessions less ), Without altering the number of complications. Theoretically, corticosteroids are the most appropriate choice due to their mechanism of action, modulating wound healing by preventing inflammation, by reducing prolyl hydroxylase, which helps reduce collagen production. However, treatment with corticosteroids, especially at high oral doses, can cause several adverse effects, such as immunosuppression, diabetes, psychiatric disorders, osteoporosis, optic lesion and peptic ulcer. Thus, the use of local corticosteroid injection could minimize these side effects. However, local injection implies risks of bleeding and perforation, and is of limited use in patients receiving anticoagulant or antiplatelet therapy. The objective of this study was to compare the local corticosteroid injection and the use of oral corticosteroids to prevent stenosis after extensive submucosal endoscopic resection of superficial esophageal carcinoma, in relation to the stenosis rate, number of dilations necessary to resolve the stenosis and frequency of complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Stenosis
Keywords
endoscopy submucosal dissection, ESD, esophageal stenosis, esophageal stricture, steroid injection, oral prednisolone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local steroid-triamcinolone acetonide
Arm Type
Experimental
Arm Description
Local steroid (triamcinolone acetonide) injection to the ulcer immediately after ESD. Total amount of injected triamcinolone is 100 mg.
Arm Title
Oral steroid-predonisolone
Arm Type
Active Comparator
Arm Description
(predonisolone) administration three days after ESD. Predonisolone is administered over 8 weeks, started at 30 mg/day and tapered 30, 30, 25, 25, 20, 15, 10 and 5 every 7 days, totaling 8 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
Local steroid - triamcinolone acetonide
Intervention Description
(triamcinolone acetonide)
Intervention Type
Drug
Intervention Name(s)
Oral steroid - predonisolone
Intervention Description
(predonisolone)
Primary Outcome Measure Information:
Title
Early Stenosis rate
Description
Stenosis to the passage of the standard endoscopic (9.8 mm)
Time Frame
12 weeks
Title
Late Stenosis rate
Description
Stenosis to the passage of the standard endoscopic (9.8 mm)
Time Frame
24 weeks
Title
Early resistance rate
Description
Resistance to the passage of the standard endoscopic (9.8 mm)
Time Frame
12 weeks
Title
Late resistance rate
Description
Resistance to the passage of the standard endoscopic (9.8 mm)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Number of dilations to solve the stenosis
Description
Number of endoscopic dilations (Savary or balloon)
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Complications
Description
Complications related to the procedure and preventive therapy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference; Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT; Signed informed consent form Exclusion Criteria: Presence of invasive esophageal neoplasia Hepatical cirrhosis Diabetes mellitus with fasting glycemia above 200mg% Use of corticosteroids in the 30 days prior to ESD INR> 1.5 Platelet count less than 50,000 Active gastrointestinal ulcer Severe psychiatric illness Glaucoma History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fauze Maluf-Filho, PhD
Phone
55 11 99191-9014
Email
fauze.maluf@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Joel F Oliveira, MD
Phone
55 11 96382-0289
Email
jfoliveira1@gmail.com
Facility Information:
Facility Name
Instituto do Câncer do Estado de São Paulo - ICESP
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fauze Fauze-Maluf, MD, PHD
Phone
5511991919014
Email
fauze.maluf@terra.com.br
First Name & Middle Initial & Last Name & Degree
Fauze Maluf-FIlho, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture

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