Endoscopic Stenting versus conservative treatment of esophago-enteric anastomotic leakages

Phase 3

Recruiting

• Conditions: C15; C16; Malignant neoplasm of oesophagus; Malignant neoplasm of stomach

• Registration Number: DRKS00007941
• Lead Sponsor: niversitätsklinikum Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Histological confirmed esophageal or gastric cancer or a similar surgically treated malignancy (e.g. GIST) 2.Esophagectomy or gastrectomy with an intrathiracic or intraabdominal esophago-enteric anastomosis 3.Radiologically or endoscopically verified leakage 4.Clinical symptoms or elevated inflammatory lab results due to the leakage 5.Age over 18 years 6.Ability to understand and willingness to consent to formal requirements for study participation 7.Written informed consent

Exclusion Criteria

1. Macroscopical incomplete resection(R2) 2.Endoscopically verified conduit necrosis 3.Leakage size over 2/3 of circumference4.Early leakage (<48 hours after surgery) 5. Pregnant or breast-feeding women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of leakage healing (radiologically or endoscopical confirmed) or hospital discharge on day 44 after primary surgery

Secondary Outcome Measures

Name	Time	Method
1. Hospitalization 2. Rate of treatment failure 3. Rate of a need of surgical revision and its kind 4. Complications 5.Mortality 6.ICU-time 7.SOFA-Score 8.Artificial ventilation time 9.Quality of life 10.Duration of leakage therapy 11.Time until endoscopical verified healing 12.Time until perusal nutrition 13. Direct costs 14. Symptomatic stenosis rate after 1 year