Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures

Conditions

• Refractory Benign Esophageal Strictures

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fully covered self-expandable metal esophageal stent — DEVICE
  Esophageal stent placement for patients with benign esophageal strictures not responding to endoscopic dilations.

Study Details

This project is being done to compare two current treatment clinical options for management of RBES: 1) Frequent dilations followed by temporary esophageal stent placement if dilations fail, or 2) Early stent placement followed by dilations

Key Dates

Start date

Oct 14, 2025

Status verified

Oct 2025

Primary completion

Mar 21, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Late-stent approach
  Repeated dilations at weekly intervals, and based on the response, the intervals between dilations are adjusted, and if still no response, place a removable FCSEMS (18 mm diameter). The stent will be removed in 2 weeks followed again by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.
• Active Comparator: Early-stent approach
  Removable FCSEMS (18 mm diameter) placed on index endoscopy and removed after 2 weeks followed by weekly dilations till less than one dilation is needed every 3 months to maintain a luminal diameter of 14 mm or more.

Primary Outcome Measure

Time to achieve esophageal luminal diameter to ≥14 mm [ Time Frame: From enrollment to follow up, up to 2 years ]

Locations (1)

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