AzTrials
AzTrials

Esophageal StrictureNCT06626802

Steroid Versus Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture

A study testing Balloon Dilation + Topical Mitomycin and Balloon Dilation + Injection Triamcinolone in people with Esophageal Stricture, run by King Edward Medical University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS). Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Esophageal Stricture
What is being tested?
Balloon Dilation + Topical Mitomycin and Balloon Dilation + Injection Triamcinolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 sitePakistan
Study dates
1 Jul 2023to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients up to 16 years of age belonging to both genders
  • Patients with single esophageal stricture
  • Patients with benign recurrent esophageal strictures
  • Patients with any etiology for esophageal stricture including; post-corrosive, congenital, post-anastomotic and eosinophilic.

Who cannot join

  • Patients unfit for anesthesia and/or hemodynamic instability
  • Patients with hemostatic disorder (platelets <50,000 or international normalized ratio >1.5)
  • Patients who have undergone esophageal surgery in last one month
  • Patients with complications such as; stricture perforation, signs of air leak or mediastinitis
  • Those with hypersensitivity to Mitomycin- C
  • Patients with multiple strictures

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Children Hospital and University of Child Health Sciences Lahore

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Intralesional Steroid Injection Versus Topical Mitomycin-C Use in Pediatric Benign Recurrent Esophageal Stricture: A Randomized Control Trial

To compare the efficacy of steroid injection versus topical mitomycin-C in the treatment of pediatric benign recurrent esophageal strictures. The rationale for this study is to compare the two therapeutic options in order to measure their effectiveness, in terms of improvement of Dysphagia Severity Score (DSS).

Read the detailed description

After taking approval from the Institutional Review Board of the university; and taking the informed consent from parents, patients fulfilling the inclusion and exclusion criteria will be enrolled in the study. They will be then randomly allocated into two groups; group A and group B. Patients in Group A will be treated with esophageal dilation with a CRE balloon (controlled radial expansion balloon). After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. Patients in Group B will be treated with esophageal dilation with a CRE balloon in the same manner. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Dysphagia Severity Score will be noted at start of intervention, at 2 weeks after intervention and at 6 weeks post- intervention.

Being tested
Balloon Dilation + Topical Mitomycin, Balloon Dilation + Injection Triamcinolone
Keywords
Esophageal stricture, Mitomycin, Triamcinolone, Dysphagia
Medical subject headings
Esophageal Stenosis, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balloon Dilation + Topical MitomycinProcedure or surgery

    Patients with recurrent esophageal strictures in Group A will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Mitomycin applied topically at stricture site (post dilation)

  • Balloon Dilation + Injection TriamcinoloneProcedure or surgery

    Patients with recurrent esophageal strictures in Group B will undergo endoscopy and balloon dilation with a CRE balloon, followed by injection Triamcinolone, injected with a sclerotherapy injector, at stricture site (post dilation)

Study groups in NCT06626802
Study groupRoleWhat they receive
Group A: MitomycinExperimentalPatients in Group A will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, injection Mitomycin will be applied to the narrowest portion of the stricture. It will be applied in a dose of 1ml (0.4mg/ml); after dividing in to four aliquots, each aliquot will be applied to to one of the four quadrants.
Receives: Procedure: Balloon Dilation + Topical Mitomycin
Group B: TriamcinoloneExperimentalPatients in Group B will be treated with esophageal dilation with a CRE balloon. After adequate dilation of stricture, Triamcinolone injection will be injected into the narrowest portion of the stricture, using a sclerotherapy injector. Injection triamcinolone will be used in a dose of 1ml (40mg/ml). It will be divided in to four aliquots; each aliquot will be injected in to each of the four quadrants.
Receives: Procedure: Balloon Dilation + Injection Triamcinolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS)

    Patients in both groups (group A and group B) will be followed and mean dysphagia severity score will be noted at 0, 2 and 6 weeks of intervention in both the groups. Improvement in dysphagia will be monitored via a validated Dysphagia Severity Score (DSS). It is as follows:

    0 Able to eat normal diet/no dysphagia

    1. Able to swallow some solid foods
    2. Able to swallow only semi solid foods
    3. Able to swallow liquids only
    4. Unable to swallow anything/total dysphagia

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start1 Jul 2023
  3. Primary completion30 Jun 2024
  4. Study completion30 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06626802
Sponsor's protocol ID
PedEsoStricture
Status last verified
Oct 2024
First submitted
24 Sep 2024
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sarma MS, Tripathi PR, Arora S. Corrosive upper gastrointestinal strictures in children: Difficulties and dilemmas. World J Clin Pediatr. 2021 Nov 9;10(6):124-136. doi: 10.5409/wjcp.v10.i6.124. eCollection 2021 Nov 9.

    PubMed 34868889

  • Al Sarkhy AA, Saeed A, Hamid YH, Al Asmi MM, Altokhais TI, Ullah AA, Assiri AM. Efficacy and safety of endoscopic dilatation in the management of esophageal strictures in children. Saudi Med J. 2018 Aug;39(8):787-791. doi: 10.15537/smj.2018.8.22845.

    PubMed 30106416

  • Boregowda U, Goyal H, Mann R, Gajendran M, Patel S, Echavarria J, Sayana H, Saligram S. Endoscopic management of benign recalcitrant esophageal strictures. Ann Gastroenterol. 2021;34(3):287-299. doi: 10.20524/aog.2021.0585. Epub 2021 Jan 27.

    PubMed 33948052

  • Ravich WJ. Endoscopic Management of Benign Esophageal Strictures. Curr Gastroenterol Rep. 2017 Aug 24;19(10):50. doi: 10.1007/s11894-017-0591-8.

    PubMed 28840483

  • Shahein AR, Krasaelap A, Ng K, Bitton S, Khan M, Manfredi MA, Lerner DG. Esophageal Dilation in Children: A State of the Art Review. J Pediatr Gastroenterol Nutr. 2023 Jan 1;76(1):1-8. doi: 10.1097/MPG.0000000000003614. Epub 2022 Sep 19.

    PubMed 36122370

  • Divarci E, Celtik U, Dokumcu Z, Ozcan C, Erdener A. The Efficacy of Intralesional Steroid Injection in the Treatment of Corrosive Esophageal Strictures in Children. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):e122-e125. doi: 10.1097/SLE.0000000000000351.

    PubMed 27846162

  • Dasari CS, Jegadeesan R, Patel HK, Desai M, Aziz M, Thoguluvachandrasekar V, Duvvuri A, Kohli DR, Repici A, Siersema PD, Sharma P. Intralesional steroids and endoscopic dilation for anastomotic strictures after esophagectomy: systematic review and meta-analysis. Endoscopy. 2020 Sep;52(9):721-726. doi: 10.1055/a-1172-5975. Epub 2020 May 25.

    PubMed 32450581

  • Mendez-Nieto CM, Zarate-Mondragon F, Ramirez-Mayans J, Flores-Flores M. Topical mitomycin C versus intralesional triamcinolone in the management of esophageal stricture due to caustic ingestion. Rev Gastroenterol Mex. 2015 Oct-Dec;80(4):248-54. doi: 10.1016/j.rgmx.2015.07.006. Epub 2015 Oct 9. English, Spanish.

    PubMed 26455483

Questions about this trial

What is this clinical trial studying?

A study testing Balloon Dilation + Topical Mitomycin and Balloon Dilation + Injection Triamcinolone in people with Esophageal Stricture, run by King Edward Medical University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness measured in terms of improvement in Dysphagia Severity Score (DSS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06626802, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in