NCT06917222

Brief Summary

Aim of the Work To compare the clinical outcomes between patients will undergo slide tracheoplasty and those will undergo tracheal resection anastomosis for acquired tracheal stenosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
May 2025Aug 2026

First Submitted

Initial submission to the registry

April 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

April 1, 2025

Last Update Submit

September 22, 2025

Conditions

Tracheal StenosisSubglottic Stenosis

Keywords

Slide tracheoplastyTracheal resection anastomosis

Outcome Measures

Primary Outcomes (1)

  • Success Rate of Procedure

    Defined as the absence of stridor or the need for re-intervention within a defined follow-up period (3 months

    3-6 months

Secondary Outcomes (3)

  • Complication Rates

    3 months

  • Duration of Hospital Stay

    3 months

  • Time to Decannulation

    3 months

Study Arms (2)

Slide tracheoplasty

EXPERIMENTAL
Procedure: Slide tracheoplasty

Tracheal resection anastomosis

EXPERIMENTAL
Procedure: Tracheal resection anastomosis

Interventions

Slide tracheoplastyPROCEDURE

Management of tracheal stenosis by slide tracheoplasty

Slide tracheoplasty
Tracheal resection anastomosisPROCEDURE

Management of tracheal stenosis by tracheal resection anastomosis

Tracheal resection anastomosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with grade III, IV acquired tracheal stenosis (e.g., due to trauma, prolonged intubation) regardless their age or sex.
  • Patient with symptomatic high grade II acquired laryngotracheal stenosis after failure of endoscopic interventions.
  • Clinical indications for surgical intervention (Symptoms of airway obstruction).
  • Feasible for surgical intervention.

You may not qualify if:

  • congenital tracheal stenosis
  • Malignant stenosis.
  • Severe comorbidities that contraindicate the surgery.
  • Patients refusing to sign the consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eslam Hamed

Al Mansurah, Egypt

RECRUITING

Related Publications (10)

  • Bocage JP, Caccavale R, Lewis R, Sisler G, MacKenzie J. Tracheal stenosis. N J Med. 1990 Aug;87(8):631-4.

    PMID: 2395535BACKGROUND

  • de Alarcon A, Rutter MJ. Cervical slide tracheoplasty. Arch Otolaryngol Head Neck Surg. 2012 Sep;138(9):812-6. doi: 10.1001/archoto.2012.1768.

    PMID: 22986713BACKGROUND

  • Freitag L, Darwiche K. Endoscopic treatment of tracheal stenosis. Thorac Surg Clin. 2014 Feb;24(1):27-40. doi: 10.1016/j.thorsurg.2013.10.003.

    PMID: 24295657BACKGROUND

  • Grillo HC. Surgical treatment of postintubation tracheal injuries. J Thorac Cardiovasc Surg. 1979 Dec;78(6):860-75.

    PMID: 502569BACKGROUND

  • Li C, Rutter MJ. Acquired tracheal stenosis: Cervical slide tracheoplasty. Semin Pediatr Surg. 2021 Jun;30(3):151058. doi: 10.1016/j.sempedsurg.2021.151058. Epub 2021 May 25.

    PMID: 34172213BACKGROUND

  • Manning PB, Rutter MJ, Lisec A, Gupta R, Marino BS. One slide fits all: the versatility of slide tracheoplasty with cardiopulmonary bypass support for airway reconstruction in children. J Thorac Cardiovasc Surg. 2011 Jan;141(1):155-61. doi: 10.1016/j.jtcvs.2010.08.060. Epub 2010 Nov 5.

    PMID: 21055774BACKGROUND

  • Schweiger C, Cohen AP, Rutter MJ. Tracheal and bronchial stenoses and other obstructive conditions. J Thorac Dis. 2016 Nov;8(11):3369-3378. doi: 10.21037/jtd.2016.11.74.

    PMID: 28066618BACKGROUND

  • Smith MM, Cotton RT. Diagnosis and management of laryngotracheal stenosis. Expert Rev Respir Med. 2018 Aug;12(8):709-717. doi: 10.1080/17476348.2018.1495564. Epub 2018 Jul 12.

    PMID: 29969925BACKGROUND

  • Tsang V, Murday A, Gillbe C, Goldstraw P. Slide tracheoplasty for congenital funnel-shaped tracheal stenosis. Ann Thorac Surg. 1989 Nov;48(5):632-5. doi: 10.1016/0003-4975(89)90777-7.

    PMID: 2818051BACKGROUND

  • Zalzal HG, Behzadpour HK, Leonard J, Sinha P, Preciado DA. Systematic Review of Slide Tracheoplasty Outcomes. Ann Otol Rhinol Laryngol. 2023 May;132(5):558-565. doi: 10.1177/00034894221104955. Epub 2022 Jun 20.

    PMID: 35723210BACKGROUND

MeSH Terms

Conditions

Tracheal Stenosis

Condition Hierarchy (Ancestors)

Tracheal DiseasesRespiratory Tract Diseases

Central Study Contacts

Eslam Hamed Abdou, Assistant lecturer

CONTACT

+201015566532eslamhamed@mans.edu.eg

Ahmed Elsobki, Associated professor

CONTACT

+20 122 7505929Ahmedelsobkyorl@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 1, 2025

First Posted

April 8, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 25, 2025

Record last verified: 2025-04

Locations

EG(1)