EUCTR2016-001853-41-NL
Active, not recruiting
Phase 1
Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial - INCA trial
Academic Medical Center0 sites89 target enrollmentOctober 17, 2016
ConditionsBenign esophagogastric anastomotic strictures after esophagectomyMedDRA version: 20.0Level: LLTClassification code 10030199Term: Oesophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: LLTClassification code 10015449Term: Esophageal strictureSystem Organ Class: 100000004856MedDRA version: 20.0Level: PTClassification code 10030215Term: OesophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 20.0Level: LLTClassification code 10015460Term: EsophagectomySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsKenacort-A 40
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Benign esophagogastric anastomotic strictures after esophagectomy
- Sponsor
- Academic Medical Center
- Enrollment
- 89
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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