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Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03898661
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Gastro-enterologie, University Hospital, Ghent

Brief Summary:
In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture followed by dilation 24 hours later improves the outcome of patients with refractory esophageal anastomotic strictures as compared to dilation alone (standard of care).

Condition or disease Intervention/treatment Phase
Stricture Esophageal Stricture Anastomotic Collagenosis Drug: Collagenase histiolyticum Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Injection of Collagenase Clostridium Histolyticum (XiapexR) for Refractory Iatrogenic Esophageal Strictures: an Open-label Pilot Study
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: local collagenase
Patients receiving local injection of collagenase into the esophageals stricture
Drug: Collagenase histiolyticum
local injection of collagenase histiolyticum into the esophageal stricture, 1 day before balloon dilation

Primary Outcome Measures :
  1. Number of repeat dilations that are required over a timespan of 6 months. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. time to first repeat dilation [ Time Frame: 6 months ]
  2. complication rate. [ Time Frame: 6 months ]
  3. Dysphagia score [ Time Frame: 6 months ]
    (0: no dysphagia, able to eat normal diet; 1: moderate passage: able to eat some solid foods; 2: poor passage: able to eat semi-solid foods only; 3: very poor passage: able to swallow liquids only; 4: no passage: unable to swallow anything)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The patient is 18-90 years old The patient suffers from dysphagia caused by an iatrogenic esophageal stricture The stricture is amenable for endoscopic dilation The patient has undergone at least 1 previous endoscopic dilation for the same stricture The patient has signed the ICF

Exclusion Criteria:

The patient is not fluent in Dutch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03898661

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Hindryckx Recruiting
Zwijnaarde, Belgium, 9052
Contact: Pieter Hindryckx, MD, PhD    +32 9 332 07 26   
Principal Investigator: Pieter Hindryckx, MD, PhD         
Sub-Investigator: Danny De Looze, MD, PhD         
Sub-Investigator: David Tate, MD         
Sponsors and Collaborators
University Hospital, Ghent
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Responsible Party: Gastro-enterologie, MD, PhD, University Hospital, Ghent Identifier: NCT03898661    
Other Study ID Numbers: AGO/2018/004
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gastro-enterologie, University Hospital, Ghent:
esophageal stricture
Additional relevant MeSH terms:
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Esophageal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases