Intensive endoscopic therapy compared with standard endoscopic therapy for newly diagnosed benign strictures in the esophagus that developed after esophageal resectio

Phase 1

• Conditions: Benign esophagogastric anastomotic strictures after esophagectomy; MedDRA version: 20.0Level: LLTClassification code 10030199Term: Oesophageal strictureSystem Organ Class: 100000004856; MedDRA version: 20.0Level: LLTClassification code 10015449Term: Esophageal strictureSystem Organ Class: 100000004856; MedDRA version: 20.0Level: PTClassification code 10030215Term: OesophagectomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10015460Term: EsophagectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-001853-41-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-17
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

•Untreated benign esophagogastric anastomotic stricture after esophagectomy.
•The stricture should be suitable for endoscopic incision:
-Diagnosed at least 6 weeks after esophagectomy, and
-Stricture length = 1 cm.
•Dysphagia score = 2 = ability to swallow semi-solid food or worse.
•Age > 18 years.
•Written informed consent for study participation.
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 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 89

Exclusion Criteria

•Benign esophageal stricture other than an esophagogastric anastomotic stricture.
•Strictures with a morphology unsuitable for needle-knife incision, such as long (> 1 cm), irregulair or tortuous strictures.
•Previous endoscopic treatment of the esophageal stricture, such as bougie/balloon dilation, steroid injection, incision therapy or stent placement.
•Previous stent placement post-esophagectomy for anastomotic leakage.
•(Suspicion of) recurrent or metastasized esophageal cancer.
•Persisting postoperative esophageal fistula.
•Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued.
•Known clotting disorder.
•Patients unable to provide written consent for the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To prolong the dysphagia-free period for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy;Secondary Objective: To reduce the number of endoscopic dilations for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy;Primary end point(s): The dysphagia-free period;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Total number of endoscopic dilation procedures.<br>•Number of days from the first endoscopic procedure to the ability to tolerate a normal diet.<br>•The technical success of the intensive endoscopic therapy and conventional repeated endoscopic bougie dilation.<br>•Procedure-related complications.<br>•Therapy satisfaction score.<br>;Timepoint(s) of evaluation of this end point: 14 days and thereafter monthly evaluation until 6 months of follow-up have been completed