NCT04498260

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2019

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

August 4, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

January 30, 2019

Last Update Submit

July 30, 2020

Conditions

Esophageal Stenosis

Keywords

endoscopy submucosal dissectionESDesophageal stenosisesophageal stricturesteroid injectionoral prednisolone

Outcome Measures

Primary Outcomes (4)

  • Early Stenosis rate

    Stenosis to the passage of the standard endoscopic (9.8 mm)

    12 weeks

  • Late Stenosis rate

    Stenosis to the passage of the standard endoscopic (9.8 mm)

    24 weeks

  • Early resistance rate

    Resistance to the passage of the standard endoscopic (9.8 mm)

    12 weeks

  • Late resistance rate

    Resistance to the passage of the standard endoscopic (9.8 mm)

    24 weeks

Secondary Outcomes (1)

  • Number of dilations to solve the stenosis

    24 weeks

Other Outcomes (1)

  • Complications

    24 weeks

Study Arms (2)

Local steroid-triamcinolone acetonide

EXPERIMENTAL

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

Drug: Local steroid - triamcinolone acetonide

Oral steroid-predonisolone

ACTIVE COMPARATOR

(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.

Drug: Oral steroid - predonisolone

Interventions

Local steroid - triamcinolone acetonideDRUG

(triamcinolone acetonide)

Local steroid-triamcinolone acetonide
Oral steroid - predonisoloneDRUG

(predonisolone)

Oral steroid-predonisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Câncer do Estado de São Paulo - ICESP

São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Fauze Maluf-Filho, PhD

CONTACT

55 11 99191-9014fauze.maluf@terra.com.br

Joel F Oliveira, MD

CONTACT

55 11 96382-0289jfoliveira1@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2019

First Posted

August 4, 2020

Study Start

January 21, 2019

Primary Completion

March 21, 2021

Study Completion

June 21, 2021

Last Updated

August 4, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)