4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy (EsoLeak)

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

Study Description
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.

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

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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 self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
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 in the area of the esophagogastric anastomotic leaks
Other Name: Negative pressure wound therapy
Outcome Measures
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 and EVT with a questionnaire by EORTC QLQ - OES18. This Questionnaire was developed to assess the quality of life of cancer patients.


Eligibility Criteria
Layout table for eligibility information
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).
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Seung-Hun Chon, MD +49221478 4864 seung-hun.chon@uk-koeln.de
Contact: Christiane Bruns, MD 0049221 478 4801 Christiane.bruns@uk-koeln.de

Locations
Layout table for location information
Germany
University Hospital of Cologne
Cologne, NRW, Germany, 50937
Contact: SeungHun Chon, MD    +49 221 478 4864    seung-hun.chon@uk-koeln.de   
Principal Investigator: Seung-Hun Chon, MD         
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany
Contact: Michael Tachezy, MD       mtachezy@uke.de   
Sponsors and Collaborators
University Hospital of Cologne
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Principal Investigator: Seung-Hun Chon, MD University Hospital of Cologne
Principal Investigator: Michael Tachezy, MD Universitätsklinikum Hamburg-Eppendorf (UKE)
Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 23, 2019
Last Update Posted Date April 29, 2021
Estimated Study Start Date May 1, 2021
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 23, 2019) 		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.
Original Primary Outcome Measures
 (submitted: May 22, 2019) 		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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stent Therapy Versus Endoscopic Vacuum Therapy for Anastomotic Leaks After Esophagectomy
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).
Condition Leaks, Anastomotic
Intervention
  • Device: EsoSponge
    Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
    Other Name: Negative pressure wound therapy
  • Device: Self-Expanding Metal Stent
    Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
    Other Name: SEMS, stent
Study Groups/Cohorts
  • SEMS Group
    The outcome of using self-expanding metal stents (SEMS) in the treatment of postoperative leakage after esophagogastrostomy
    Intervention: Device: Self-Expanding Metal Stent
  • EVT Group
    The outcome of using endoscopic vacuum therapy (EVT) in the treatment of postoperative leakage after esophagogastrostomy
    Intervention: Device: EsoSponge
Publications *
  • Bartella I, Mallmann C, Bürger M, Toex U, Goeser T, Bruns C, Chon SH. Stent-over-sponge (SOS): a rescue option in patients with complex postoperative anastomotic leaks after esophagectomy. Endoscopy. 2019 Aug;51(8):E227-E228. doi: 10.1055/a-0885-9659. Epub 2019 May 2.
  • Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Hölscher AH, Chon SH. Self-Expanding Metal Stents Versus Endoscopic Vacuum Therapy in Anastomotic Leak Treatment After Oncologic Gastroesophageal Surgery. J Gastrointest Surg. 2019 Jan;23(1):67-75. doi: 10.1007/s11605-018-4000-x. Epub 2018 Oct 29.
  • Grimminger PP, Goense L, Gockel I, Bergeat D, Bertheuil N, Chandramohan SM, Chen KN, Chon SH, Denis C, Goh KL, Gronnier C, Liu JF, Meunier B, Nafteux P, Pirchi ED, Schiesser M, Thieme R, Wu A, Wu PC, Buttar N, Chang AC. Diagnosis, assessment, and management of surgical complications following esophagectomy. Ann N Y Acad Sci. 2018 Dec;1434(1):254-273. doi: 10.1111/nyas.13920. Epub 2018 Jul 8. Review.
  • Chon SH, Toex U, Plum PS, Fuchs C, Kleinert R, Bruns C, Goeser T. Successful closure of a gastropulmonary fistula after esophagectomy using the Apollo Overstitch and endoscopic vacuum therapy. Endoscopy. 2018 Jul;50(7):E149-E150. doi: 10.1055/a-0592-6384. Epub 2018 Apr 13.
  • Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Hölscher AH, Schröder W, Chon SH. Results of endoscopic vacuum-assisted closure device for treatment of upper GI leaks. Surg Endosc. 2018 Apr;32(4):1906-1914. doi: 10.1007/s00464-017-5883-4. Epub 2017 Dec 7.
  • Tachezy M, Chon SH, Rieck I, Kantowski M, Christ H, Karstens K, Gebauer F, Goeser T, Rösch T, Izbicki JR, Bruns CJ. Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial. Trials. 2021 Jun 2;22(1):377. doi: 10.1186/s13063-021-05315-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 22, 2019) 		40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Seung-Hun Chon, MD +49221478 4864 seung-hun.chon@uk-koeln.de
Contact: Christiane Bruns, MD 0049221 478 4801 Christiane.bruns@uk-koeln.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03962244
Other Study ID Numbers 19-1201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Seung-Hun Chon, University Hospital of Cologne
Study Sponsor University Hospital of Cologne
Collaborators Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Seung-Hun Chon, MD University Hospital of Cologne
Principal Investigator: Michael Tachezy, MD Universitätsklinikum Hamburg-Eppendorf (UKE)
PRS Account University Hospital of Cologne
Verification Date April 2021

治疗医院

新药特效药

治疗案例

前沿医讯