An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children

NCT06675825 | Recruiting

• 2 other identifiers: BASEC2023-D0111SNCTP000005847
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this study is to find out if using the BougieCap device is a safe and effective way to stretch narrow areas in the esophagus (food pipe) in children. The main questions this study wants to answer are:

• Does the BougieCap work well to treat narrow areas in the esophagus comparing with other methods to widen these narrow areas?
• Is BougieCap easy to use and does it cause fewer problems or discomfort for children? Researchers will compare two groups: one using the BougieCap, and the other using traditional methods like balloon dilation, to see which one works better and is safer. Participants will:
• Answer questions about their symptoms before treatment, 24 hours after, and 14 days later.
• Complete these questions during regular hospital visits or over the phone for the final check-up. This study does not involve any extra risks or burdens for the participants.

Conditions

Esophageal Stenosis; Esophageal Dilation

Keywords

esophageal stricture; esophageal dilation; pediatric gastroenterology

Outcome Measures

Primary Outcomes (1)

• Successful dilation

  Satisfactory dilation of the stenosis according to the operator

  Directly after the intervention

Study Arms (2)

Study Group 1: BougieCap

EXPERIMENTAL

Patients randomized into this group will undergo the dilation using the BougieCap.

Device: BougieCap

Study Group 2: Standard treatment

ACTIVE COMPARATOR

Patients randomized to the standard treatment arm will be provided one of the two standard dilation techniques, Savary- Bougie dilation or balloon dilation. This procedure could take place under endoscopic or radiological control.

Device: Savary-Bougie (A) or balloon dilation (B)

Interventions

BougieCap DEVICE

The BougieCap is attached to the tip of the endoscope, offers direct visual and tactile control and the endoscope acts as a carrier of the radial and longitudinal force vectors for the dilation.

Also known as: Esophageal dilation

Study Group 1: BougieCap

Savary-Bougie (A) or balloon dilation (B) DEVICE

A: In the Savary- Bougie treatment, dilators of different sizes are advanced to dilate the stenosis. The same procedure is then repeated with the next larger dilator, with the position of the dilator being checked radiologically each time. B: In the case of balloon dilation, a balloon is inserted and inflated at the level of the stenosis. Depending on the age of the child and possibly also the etiology of the stenosis, different balloons sizes are applied, which are then maintained inflated for about one until three minutes and the respective pressure. This procedure could take place under endoscopic or radiological control.

Also known as: Dilation of esophageal stricture, Esophageal dilation

Study Group 2: Standard treatment

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age under 18 years of age
• Indication for endoscopic esophageal dilation
• Benign stenosis
• Written Informed Consent signed by the subject and/or parent/legal representative (if applicable)

You may not qualify if:

• Stenosis that cannot be treated endoscopically
• Malignant esophageal strictures
• Contraindications and limitations of the MD as described in the instructions for use

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (3)

Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,

Rome, 00161, Italy

RECRUITING

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

Universitäts-Kinderspital beider Basel

Basel, 4056, Switzerland

RECRUITING

Related Publications (13)

• Schoepfer AM, Henchoz S, Biedermann L, Schreiner P, Greuter T, Reinhard A, Senn J, Franke A, Burri E, Juillerat P, Simon HU, Straumann A, Safroneeva E, Godat S. Technical feasibility, clinical effectiveness, and safety of esophageal stricture dilation using a novel endoscopic attachment cap in adults with eosinophilic esophagitis. Gastrointest Endosc. 2021 Nov;94(5):912-919.e2. doi: 10.1016/j.gie.2021.05.017. Epub 2021 May 15.

  PMID: 34004192 BACKGROUND

• Lafeuille P, Yzet C, Bonniaud P, Rostain F, Ponchon T, Rivory J, Pioche M. Use of a bougie-shaped cap for dilation with direct visual control for an esophageal stricture induced by radiation therapy. Endoscopy. 2023 Dec;55(S 01):E18-E19. doi: 10.1055/a-1929-9317. Epub 2022 Sep 16. No abstract available.

  PMID: 36113487 BACKGROUND

• Walter B, Schmidbaur S, Rahman I, Albers D, Schumacher B, Meining A. The BougieCap - a new method for endoscopic treatment of complex benign esophageal stenosis: results from a multicenter study. Endoscopy. 2019 Sep;51(9):866-870. doi: 10.1055/a-0959-1535. Epub 2019 Jul 23.

  PMID: 31342473 BACKGROUND

• Ghiselli A, Bizzarri B, Ferrari D, Manzali E, Gaiani F, Fornaroli F, Nouvenne A, Di Mario F, De'Angelis GL. Endoscopic dilation in pediatric esophageal strictures: a literature review. Acta Biomed. 2018 Dec 17;89(8-S):27-32. doi: 10.23750/abm.v89i8-S.7862.

  PMID: 30561414 BACKGROUND

• Dall'Oglio L, Caldaro T, Foschia F, Faraci S, Federici di Abriola G, Rea F, Romeo E, Torroni F, Angelino G, De Angelis P. Endoscopic management of esophageal stenosis in children: New and traditional treatments. World J Gastrointest Endosc. 2016 Feb 25;8(4):212-9. doi: 10.4253/wjge.v8.i4.212.

  PMID: 26962403 BACKGROUND

• Jones MP, Bratten JR, McClave SA. The Optical Dilator: a clear, over-the-scope bougie with sequential dilating segments. Gastrointest Endosc. 2006 May;63(6):840-5. doi: 10.1016/j.gie.2005.08.042.

  PMID: 16650550 BACKGROUND

• Clark SJ, Staffa SJ, Ngo PD, Yasuda JL, Zendejas B, Hamilton TE, Jennings RW, Manfredi MA. Rules Are Meant to Be Broken: Examining the "Rule of 3" for Esophageal Dilations in Pediatric Stricture Patients. J Pediatr Gastroenterol Nutr. 2020 Jul;71(1):e1-e5. doi: 10.1097/MPG.0000000000002687.

  PMID: 32141993 BACKGROUND

• Cakmak M, Boybeyi O, Gollu G, Kucuk G, Bingol-Kologlu M, Yagmurlu A, Aktug T, Dindar H. Endoscopic balloon dilatation of benign esophageal strictures in childhood: a 15-year experience. Dis Esophagus. 2016 Feb-Mar;29(2):179-84. doi: 10.1111/dote.12305. Epub 2014 Dec 17.

  PMID: 25515612 BACKGROUND

• Wallner O, Wallner B. Balloon dilation of benign esophageal rings or strictures: a randomized clinical trial comparing two different inflation times. Dis Esophagus. 2014 Feb-Mar;27(2):109-11. doi: 10.1111/dote.12080. Epub 2013 Apr 26.

  PMID: 23621385 BACKGROUND

• Witzleben AV, Reiter R, Hoffmann T, Posovszky C. Buried Foreign Body in the Esophagus - Unusual Cause of Dysphagia in a 2-Year-Old Child. Klin Padiatr. 2019 Jul;231(4):214-216. doi: 10.1055/a-0942-1838. Epub 2019 Jun 17. No abstract available.

  PMID: 31207651 BACKGROUND

• 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.

  PMID: 36122370 BACKGROUND

• Collins MH, Alexander ES, Martin LJ, Grotjan TM, Mukkada VA, Sheil A, Abonia JP, Putnam PE, Rothenberg ME. Acquired Esophageal Strictures in Children: Morphometric and Immunohistochemical Analyses. Pediatr Dev Pathol. 2022 Mar-Apr;25(2):124-133. doi: 10.1177/10935266211041086. Epub 2021 Sep 13.

  PMID: 34515576 BACKGROUND

• Standards of Practice Committee; Egan JV, Baron TH, Adler DG, Davila R, Faigel DO, Gan SL, Hirota WK, Leighton JA, Lichtenstein D, Qureshi WA, Rajan E, Shen B, Zuckerman MJ, VanGuilder T, Fanelli RD. Esophageal dilation. Gastrointest Endosc. 2006 May;63(6):755-60. doi: 10.1016/j.gie.2006.02.031. No abstract available.

  PMID: 16650533 BACKGROUND

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 5, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); IT (1)