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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leaks, Anastomotic
• Intervention / Treatment: Device: Self-Expanding Metal Stent; Device: EsoSponge

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
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Seung-Hun Chon, MD; Phone Number: +49221478 4864; Email: seung-hun.chon@uk-koeln.de
• Study Contact Backup: Name: Christiane Bruns, MD; Phone Number: 0049221 478 4801; Email: Christiane.bruns@uk-koeln.de

Study Locations

• Germany
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf (UKE)
    • Contact: Michael Tachezy, MD; Email: mtachezy@uke.de
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital of Cologne
      • Contact: SeungHun Chon, MD; Phone Number: +49 221 478 4864; Email: seung-hun.chon@uk-koeln.de
      • Principal Investigator: Seung-Hun Chon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts 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 Names: 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 Names: Negative pressure wound therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction of treatment assessed by EORTC QLQ - OES18	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.	6 months

Collaborators and Investigators

• 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)

Publications and helpful links

General Publications

• Bartella I, Mallmann C, Burger 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. No abstract available.
• Berlth F, Bludau M, Plum PS, Herbold T, Christ H, Alakus H, Kleinert R, Bruns CJ, Holscher 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.
• 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. No abstract available.
• Bludau M, Fuchs HF, Herbold T, Maus MKH, Alakus H, Popp F, Leers JM, Bruns CJ, Holscher AH, Schroder 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, Rosch 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak
• Other Study ID Numbers: 19-1201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No