Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy (EsoLeak)

University Hospital of Cologne

Status: Unknown

Conditions: Leaks, Anastomotic

Treatments: Device: EsoSponge; Device: Self-Expanding Metal Stent

Study type: Observational

Funder types: Other

Identifiers

NCT03962244

19-1201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

SEMS Group

Description:

The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy

Treatment:

Device: Self-Expanding Metal Stent

EVT Group

Description:

The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy

Treatment:

Device: EsoSponge