Universität zu Köln

Tachezy, Michael, Chon, Seung-Hun ORCID: 0000-0002-8923-6428, Rieck, Isabel, Kantowski, Marcus, Christ, Hildegard, Karstens, Karl, Gebauer, Florian, Goeser, Tobias, Roesch, Thomas, Izbicki, Jakob R. and Bruns, Christiane J. (2021). Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial. Trials, 22 (1). LONDON: BMC. ISSN 1745-6215

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Abstract

BackgroundIntrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy. There are two promising endoscopic treatment strategies in the case of leaks: the placement of self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT). Up to date, there is no prospective data concerning the optimal endoscopic treatment strategy. This is a protocol description for the ESOLEAK trial, which is a first small phase 2 randomized trial evaluating the quality of life after treatment of anastomotic leaks by either SEMS placement or EVT.MethodsThis phase 2 randomized trial will be conducted at two German tertiary medical centers and include a total of 40 patients within 2 years. Adult patients with histologically confirmed esophageal cancer, who have undergone Ivor Lewis esophagectomy and show an esophagogastric anastomotic leak on endoscopy or present with typical clinical signs linked to an anastomotic leak, will be included in our study taking into consideration the exclusion criteria. After endoscopic verification of the anastomotic leak, patients will be randomized in a 1:1 ratio into two treatment groups. The intervention group will receive EVT whereas the control group will be treated with SEMS. The primary endpoint of this study is the subjective quality of life assessed by the patient using a systematic and validated questionnaire (EORTC QLQ C30, EORTC QLQ-OES18 questionnaire). Important secondary endpoints are healing rate, period of hospitalization, treatment-related complications, and overall mortality.DiscussionThe latest meta-analysis comparing implantation of SEMS with EVT in the treatment of esophageal anastomotic leaks suggested a higher success rate for EVT. The ESOLEAK trial is the first study comparing both treatments in a prospective manner. The aim of the trial is to find suitable endpoints for the treatment of anastomotic leaks as well as to enable an adequate sample size calculation and evaluate the feasibility of future interventional trials. Due to the exploratory design of this pilot study, the sample size is too small to answer the question, whether EVT or SEMS implantation represents the superior treatment strategy.Trial registrationClinicalTrials.gov NCT03962244. Registered on May 23, 2019.DRKS-ID DRKS00007941

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Tachezy, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Chon, Seung-Hun UNSPECIFIED orcid.org/0000-0002-8923-6428 UNSPECIFIED Rieck, Isabel UNSPECIFIED UNSPECIFIED UNSPECIFIED Kantowski, Marcus UNSPECIFIED UNSPECIFIED UNSPECIFIED Christ, Hildegard UNSPECIFIED UNSPECIFIED UNSPECIFIED Karstens, Karl UNSPECIFIED UNSPECIFIED UNSPECIFIED Gebauer, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Goeser, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Roesch, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Izbicki, Jakob R. UNSPECIFIED UNSPECIFIED UNSPECIFIED Bruns, Christiane J. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-580301
DOI:	10.1186/s13063-021-05315-4
Journal or Publication Title:	Trials
Volume:	22
Number:	1
Date:	2021
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUALITY-OF-LIFE; ASSISTED CLOSURE; MANAGEMENT; COMPLICATIONS; RESECTION; OUTCOMES; SURGERY; QLQ-C30; SEPSIS; IMPACT Multiple languages Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/58030