Clinical trial NCT03962244: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leaks, Anastomotic
Keywords: Esophagectomy, Esophageal Cancer, Vacuum therapy, Stents
Lead sponsor: University Hospital of Cologne
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2019-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with an intrathoracic esophago-gastric anastomotic leak after oncologic esophagectomy (Ivor-Lewis).

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.

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

Primary outcomes:
measure: Satisfaction of treatment assessed by EORTC QLQ - OES18
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: NRW
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE)
Study officials:
affiliation: University Hospital of Cologne
name: Seung-Hun Chon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf (UKE)
name: Michael Tachezy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.