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Clinical Trials/NCT03962244
NCT03962244UnknownNot Applicable

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

University Hospital of Cologne2 sites in 1 country40 target enrollmentStarted: May 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
Satisfaction of treatment assessed by EORTC QLQ - OES18
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Satisfaction of treatment assessed by EORTC QLQ - OES18

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital of Cologne
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seung-Hun Chon

PI

University Hospital of Cologne

Study Sites (2)

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