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EsoLeak: Stent Therapy Versus Endoscopic Vacuum Therapy (EsoLeak)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03962244
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Seung-Hun Chon, University Hospital of Cologne

Brief Summary:
Exploratory study of the efficiency of endoscopic stenting and endoscopic vacuum therapy in patients with intrathoracic esophago-gastric anastomotic leakage after oncological resection of an esophagus

Condition or disease Intervention/treatment
Leaks, Anastomotic Device: EsoSponge Device: Self-Expanding Metal Stent

Detailed Description:
Esophageal anastomotic leakages after Ivor Lewis esophagectomy are severe and life-threatening complications. We analyzed the outcome of using self-expanding metal stents (SEMS) and endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Management of Esophago-gastric Anastomotic Leakages: Stent Therapy Versus Endoscopic Vacuum Therapy
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
SEMS Group
The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy
Device: Self-Expanding Metal Stent
Endoscopically placed an self-expanding metal stent
Other Name: SEMS, stent

EVT Group
The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy
Device: EsoSponge
Endoscopically placed an EsoSponge for Negative pressure wound therapy
Other Name: Negative pressure wound therapy

Primary Outcome Measures :
  1. Satisfaction of treatment assessed by EORTC QLQ - OES18 [ Time Frame: 6 months ]
    Assessing the quality of life of patients during the treatment of stent or evt with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03962244

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Contact: Seung-Hun Chon, MD +49221478 4864
Contact: Christiane Bruns, MD 0049221 478 4801

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University Hospital of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
University Hospital of Cologne
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Seung-Hun Chon, MD University Hospital of Cologne

Publications of Results:

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Responsible Party: Seung-Hun Chon, PI, University Hospital of Cologne Identifier: NCT03962244     History of Changes
Other Study ID Numbers: 001
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes