Early Versus Late Endoscopic Stenting for Refractory Benign Esophageal Strictures

Официальное название

Early Versus Late Endoscopic Temporary Stenting for Management of Refractory Benign Esophageal Strictures

Обзор

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

Подробное описание

This study aims to explore the safety and effectiveness of two clinical treatment approaches used to manage RBES patients-Temporary early-stent placement versus late stenting.

For normal swallowing, the esophagus (food pipe) lumen should be equal to or more than 14 mm in diameter. In those with stricture (narrowing) of the esophagus from benign causes, initial endoscopic management is serial sessions of dilation (stretching) to achieve and maintain a diameter of ≥14mm. Many strictures may not respond to this approach (refractory). Esophageal stents (18 mm - 23 mm diameter) temporarily placed for 2 weeks using an endoscope are also used dilate and remold the stricture. While in place, patients can swallow. This can save the patient from undergoing repeated dilations. Stents can be placed either late in the process of management after several traditional dilations have failed or early in the management to rapidly achieve a diameter of ≥14 mm and then continuing traditional dilations.

Although either of above two approaches can be used for the clinical management of RBES, in this study the investigators plan to randomly assign patients to start with one of the two approaches and compare outcomes.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (2)

• Adverse event rate [Срок оценки: From enrollment to follow up, up to 2 years]
• Recurrence rate of esophageal stricture [Срок оценки: From enrollment to follow up, up to 2 years]

Критерии участия

Критерии включения

• Able to give informed and written consent.
• Able to keep follow up appointments as per protocol (minimum 2 years).
• Biopsy proven benign esophageal stricture.
• Dysphagia (grade 2 and above).
• Fit to undergo upper GI endoscopy.
• Documented esophageal stricture with a luminal diameter <14 mm at index endoscopy.

Критерии исключения

• Minimal dysphagia (grade 0-1)
• Neuromuscular dysphagia (such as achalasia, oro-pharyngeal dysphagia post-stroke, crico-pharyngeal bar, Zenker diverticulum etc.)
• Pregnant or planning to be pregnant during the study period.
• Malignant or indeterminate esophageal stricture.
• Actively receiving radiation therapy.
• Persistent associated active esophagitis that has not yet healed.
• Esophageal strictures associated with fistula/leaks/current or prior perforation.
• Eosinophilic esophagitis.
• Associated esophageal varices.
• No other malignancy limiting life expectancy.
• Patients in whom placing esophageal stents is not possible/contraindicated (such as high cervical esophageal strictures, active bleeding, metal allergy, tortuous esophagus, pseudodiverticulum with stricture).
• Previous esophageal stent tried over 2 months ago
• Significant comorbidities making patient high risk for upper GI endoscopy.
• Unable to give informed consent.
• Cannot keep follow up appointments as per protocol.
• Procedures and stents not covered by patient's insurance.
• Patients who, after comprehensive discussion and explanation of both the early-stent and late-stent approaches, choose to proceed with a specific approach and decline participation in randomization.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Froedtert Hospital — Milwaukee

Идентификаторы

NCT: NCT06991049 · PRO00054233

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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