Stenting in benign oesophageal stricture

Biodegradable stent in benign oesophageal stricture compared to standard balloon dilatation treatment: a two-arm 1:1 randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN05817794

Enrollment

Registered

2010-08-26

Start date

2010-11-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Benign oesophageal strictures Digestive System Other diseases of oesophagus

Interventions

The study will involve endoscopic interventions of balloon dilatation with or without fluroscopy in one (control) arm and placement of a biodegradable stent in the other arm. The treatment in each ar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent 2. Confirmed diagnosis of benign oesophageal stricture 3. Adults aged between 18 and 75 years, either sex 4. At least one previous oesophageal dilatation for management of their benign oesophageal stricture

Exclusion criteria

Exclusion criteria: 1. Patients who do not fulfil the inclusion criteria 2. Patients with high strictures 3. Pregnant patients 4. Receiving anti-coagulants 5. Diagnosis or oesophageal cancer 6. Diagnosis of a terminal disease 7. A history of any medical illness which, in the Investigator's discretion would inhibit the patient's participation 8. Women of child bearing potential who refuse to use adequate contraception for three months post-intervention

Design outcomes

Primary

Measure	Time frame
The average dysphagia (swallowing) score response over 12 months	—

Secondary

Measure	Time frame
1. Acceptibility of procedures to patients 2. Number of repeat endoscopic procedures 3. Frequency of refractory disease 4. Adverse events 5. Quality of life assessed physically using surrogate markers of weight, serum albumin and by generic quality of life assessment (EuroQol EQ-5D) 6. Patient level, NHS perspective, cost and cost-effectiveness analysis Measured at 3, 6 and 12 months following the endoscopic intervention in both arms	—

Measure

Time frame

1. Acceptibility of procedures to patients 2. Number of repeat endoscopic procedures 3. Frequency of refractory disease 4. Adverse events 5. Quality of life assessed physically using surrogate markers of weight, serum albumin and by generic quality of life assessment (EuroQol EQ-5D) 6. Patient level, NHS perspective, cost and cost-effectiveness analysis Measured at 3, 6 and 12 months following the endoscopic intervention in both arms

—

Countries

United Kingdom

Outcome results

None listed

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