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Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures

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ClinicalTrials.gov Identifier: NCT03898661
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
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
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)



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03898661


Locations
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Belgium
Hindryckx Recruiting
Zwijnaarde, Belgium, 9052
Contact: Pieter Hindryckx, MD, PhD    +32 9 332 07 26    pieter.hindryckx@uzgent.be   
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
ClinicalTrials.gov Identifier: NCT03898661     History of Changes
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:
Xiapex
esophageal stricture
stricture
collagenase
refractory
anastomotic

Additional relevant MeSH terms:
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Constriction, Pathologic
Esophageal Stenosis
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases