An Innovative Endoscopic Cap for Dilating Benign Esophageal Strictures in Children (BOUGIE-PED)

December 10, 2024 updated by: Vasiliki Spyropoulou, University Children's Hospital, Zurich

A Novel Endoscopic Attachment Cap for Benign Esophageal Stricture Dilation in Children: a Randomized, Multicentric Pilot Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are two categories of esophageal stricture in children: acquired and congenital. The development of benign esophageal stricture is based on significant fibromuscular alterations, inflammation in residual muscle layers and a deposition of collagen based on an inflammatory process . In children, these changes are most common in the context of a postoperative anastomotic stenosis in the case of esophageal atresia (usually type IIIb according to Vogt), as well as after caustic injury, peptic stricture and eosinophilic esophagitis. Rarely, children are born with congenital esophageal stricture. Therapeutic radiation can lead to stenoses requiring dilation. Likewise, children suffering from epidermolysis bullosa can suffer from esophageal stenosis. In rare cases, the ingestion of a foreign body in children causes symptomatic stenosis as a buried foreign body covered by esophageal hyper granulated tissue. Malignant stenosis is not considered in this study, as its treatment is different.

There are different options for endoscopic esophageal dilations of clinically relevant esophageal strictures, which promise effective treatment. Relevant strictures are usually noticed by dysphagia.

One possible dilation method uses the Savary-Gilliard bougies. These are wire-guided polyvinyl dilators. The advancement of the wire is performed under radiological fluoroscopy. Once the guide wire is placed into the stomach, the dilator is passed over the guidewire, lubricated, and pushed over the stenosis in order to dilate the stenotic area. There are also non-guidewire bougie dilators. Longitudinal shearing force and radial force occurs when the dilator passes across the stenotic area. Initially, the size of the dilator that corresponds to the diameter of the stenosis is used. The same procedure is then followed stepwise with a larger dilator of 1mm, respectively. It is generally recommended not to increase the dilator size more than 3mm in a single session.

A major disadvantage of this method is the exclusively tactile control of the dilation. At the end of the Bougie dilation, the result should be checked by reinserting the endoscope to rule out deeper mucosal injuries and persistent bleeding.

Furthermore, there is experience in the treatment of esophageal stenosis in children with balloon dilations. The balloon is inserted either blind or under endoscopic control, The balloon is then mostly inflated to 1 mm beyond the estimated stenosis diameter and the pressure is maintained for 1 minute or less. The dilation may be controlled radiologically or endoscopically. A dilation up to 5mm above the initial stricture diameter may not increase the risk of perforation. Only radial forces arise. Here, too, insufficient visual control is to be criticized. In particular, the distal area of the stenosis cannot be viewed during the procedure, or only with difficulty. In addition to the poor visual control, there is no tactile control of the dilation, since the volume of liquid applied to the balloon determines the diameter. Furthermore, there is no standard protocol for the stepwise dilation that is required for treating children at different ages. Finally, small esophageal balloons specifically for small children are missing, which is why balloon catheters from other areas and indications are used (e.g. urological balloon catheters, biliary catheters), respectively.

Due to the severely restricted visual control of the dilation with the current dilation techniques, a conical cap made of transparent plastic was developed that can be attached to the tip of standard endoscopes, the BougieCap (Ovesco, Tübingen). The cap is a single-use product, available in different outer diameters (7- 16mm) and offers direct visual and tactile control upon introduction into the upper gastrointestinal tract under visual and tactile control. The advantage of this technique is that the endoscope acts as a carrier of the radial and longitudinal force vectors for the dilation. A comparable technique is one with the optical dilator, a clear, over-the-scope bougie with sequential dilating segments. However, the limitation of this optical dilator is that it can only be used for the dilation of relatively large stenoses (from 15mm) due to the large diameter. A main reason why the optical dilator is not suitable for children.

There are currently no studies in the literature investigating the use of the BougieCap technique for treating benign esophageal strictures in children.

The aim of this randomized controlled pilot study is to demonstrate the probable efficacy of the BougieCap technique, the improvement of patient and operator dependent conditions and the absence or reduction of related adverse events such as perforations, bleeding, infections as well as the number of dilation sessions and intervals, compared to the above mentioned other techniques.

The BougieCap is an endoscopic attachment cap for bougienage/dilatation of stenoses and strictures of the upper gastrointestinal tract. No specific restrictions based on age, weight, health status or ethnicity. The decision on whether a patient is eligible for treatment with the product lies solely with the intended user. The BougieCap Ovesco is a medical device primarily composed of the cap and the adhesive tape that may come into contact with tissues (mainly Oesophagus mucosa) or bodily fluids (salive) during its application. As per regulatory standards, it's crucial to note that this device does not contain pharmaceuticals, human or animal tissues, their derivatives, or any other biologically active substances.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Recruiting
        • Maternal and Child Health Department, University Hospital - Umberto I Sapienza - University of Rome,
        • Contact:
        • Contact:
          • Salvatore Oliva, Prof. Dr. med.
  • Switzerland
      • Basel, Switzerland, 4056
        • Recruiting
        • Universitäts-Kinderspital beider Basel
        • Contact:
        • Contact:
          • Raoul I. Furlano, Prof. Dr. med.
      • Zurich, Switzerland, 8032
        • Recruiting
        • University Children's Hospital Zurich
        • Contact:
        • Contact:
          • Vasiliki Spyropoulou, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group 1: BougieCap
Patients randomized into this group will undergo the dilation using the BougieCap.
Device: BougieCap
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.
Other Names:
  • Esophageal dilation
Active Comparator: Study Group 2: Standard treatment
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)

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.

Other Names:
  • Esophageal dilation
  • Dilation of esophageal stricture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful dilation
Time Frame: Directly after the intervention
Satisfactory dilation of the stenosis according to the operator
Directly after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Children's Hospital, Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 31, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC2023-D0111
  • SNCTP000005847 (Registry Identifier: Portal for clinical trials in Switzerland (SNCTP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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