Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy

ClinicalTrials.gov ID

NCT03962244

Lead Sponsor

University Hospital of CologneOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

40Estimated

Last Update Posted

Apr 29, 2021Actual

Start Date

May 1, 2021Estimated

Primary Completion Date

Apr 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

Official Title

Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy

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.

• Leaks, Anastomotic

• EsoSponge
• Self-Expanding Metal Stent

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

University Hospital of CologneOTHER

Collaborators

Universitätsklinikum Hamburg-EppendorfOTHER

mtachezy@uke.de

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