Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy

• Conditions: Leaks, Anastomotic

• Registration Number: NCT03962244
• Lead Sponsor: University Hospital of Cologne

Brief Summary

Exploratory study of the efficiency of endoscopic stenting versus endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of the esophagus.

Detailed Description

We analyze the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-23
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-29
• Study Start: 2021-05-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically confirmed oesophageal carcinoma or similarly operated neoplasia (e.g., GIST, NET, subepithelial tumors)
• Esophagectomy with an intrathoracic esophago-gastric anastomosis
• Radiologically or endoscopically diagnosed esophago-gastric anastomotic leakage
• Clinical symptoms / symptoms due to insufficiency or increase in signs of inflammation, most likely as a result of anastomotic leakage
• Age ≥18 years
• To empower the patient to understand the scope of the study and its consequences or information, to consent to it and to sign the educational documents.
• Written declaration of consent of the patient to be included. If the patient is unable to sign by hand, a witness must confirm the oral examination by signature.

Exclusion Criteria

• Macroscopically incompletely resected tumor (R2), palliative resection
• Endoscopically verified necrosis or critical ischemia of the anastomotic region of the interponate
• Size of insufficiency more than 50% of circumference
• Impossibility of radiological interventional insertion of a drainage
• Early anastomotic leak (≤ 48 hours postoperatively), late insufficiencies (> 4 weeks)
• Therapeutic anticoagulation
• Severe septic shock that indicates surgical therapy
• Pregnant and lactating women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction of treatment assessed by EORTC QLQ - OES18	6 months	Assessing the quality of life of patients during the treatment of stent and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.

Trial Locations

Locations (2)

University Hospital of Cologne; 🇩🇪 Cologne, NRW, Germany

Universitätsklinikum Hamburg-Eppendorf (UKE); 🇩🇪 Hamburg, Germany