Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy

• Conditions: Leaks, Anastomotic
• Interventions: Device: Self-Expanding Metal Stent; Device: EsoSponge

• 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

Arm && Interventions

Group	Intervention	Description
SEMS Group	Self-Expanding Metal Stent	The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy
EVT Group	EsoSponge	The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy

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