Local injection of collagenase for difficult-to-treat scar strictures of the gastrointestinal tract.

Local injection of collagenase clostridium histolyticum (XiapexR) for refractory gastrointestinal strictures: an open-label pilot study.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003637-14-BE

Enrollment

Registered

2019-01-09

Start date

2019-03-29

Completion date

Unknown

Last updated

2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory iatrogenic gastrointestinal strictures MedDRA version: 21.0 Level: LLT Classification code 10078825 Term: Gastrointestinal anastomotic stricture System Organ Class: 100000004863

Interventions

Trade Name: Xiapex 0,9 mg powder and solution for injection Product Name: Xiapex Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: collagenase clostridium histol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient is 18-90 years old The patient suffers from a gastrointestinal stricture The stricture is amenable for endoscopic dilation The patient has undergone at least 1 previous endoscopic dilation for the same stricture within the last 3 months The patient has signed the ICF Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: The patient is not fluent in Dutch

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into a stricture followed by dilation 24 hours later improves the outcome of patients with refractory gastrointestinal strictures as compared to dilation alone (standard of care).;Secondary Objective: Not applicable.;Primary end point(s): Number of repeat dilations that are required over a timespan of 6 months.;Timepoint(s) of evaluation of this end point: 6 months after injection.	—

Measure

Time frame

Main Objective: To investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into a stricture followed by dilation 24 hours later improves the outcome of patients with refractory gastrointestinal strictures as compared to dilation alone (standard of care).;Secondary Objective: Not applicable.;Primary end point(s): Number of repeat dilations that are required over a timespan of 6 months.;Timepoint(s) of evaluation of this end point: 6 months after injection.

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Secondary

Measure	Time frame
Secondary end point(s): 1) time to first repeat dilation 2) complication rate. 3) For upper gastrointestinal strictures only: Dysphagia/gastric outlet obstruction score (0: 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 drink liquids only; 4: no oral intake possbile) 4) for lower gastrointestinal strictures only: (Ileo)colorectal obstruction scoring system (0, requiring continuous decompression; 1, no oral intake; 2, liquid or enteral nutrition; 3, oral intake of soft solids, low-residue diet, or full diet with symptoms of stricture; and 4, oral intake of soft solids, low-residue diet, or full diet without symptoms of stricture. Symptoms of stricture include abdominal pain/cramps, abdominal distension, nausea, vomiting, constipation, and diarrhea which are related to gastrointestinal transit). ;Timepoint(s) of evaluation of this end point: 6 months after injection.	—

Measure

Time frame

Secondary end point(s): 1) time to first repeat dilation 2) complication rate. 3) For upper gastrointestinal strictures only: Dysphagia/gastric outlet obstruction score (0: 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 drink liquids only; 4: no oral intake possbile) 4) for lower gastrointestinal strictures only: (Ileo)colorectal obstruction scoring system (0, requiring continuous decompression; 1, no oral intake; 2, liquid or enteral nutrition; 3, oral intake of soft solids, low-residue diet, or full diet with symptoms of stricture*; and 4, oral intake of soft solids, low-residue diet, or full diet without symptoms of stricture*. Symptoms of stricture include abdominal pain/cramps, abdominal distension, nausea, vomiting, constipation, and diarrhea which are related to gastrointestinal transit). ;Timepoint(s) of evaluation of this end point: 6 months after injection.

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Countries

Belgium

Contacts

Public ContactHIRUZ

Ghent University Hospital

hiruz.ctu@uzgent.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026