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
Highlights
Intrathoracic anastomotic leaks represent a major complication after Ivor Lewis esophagectomy
The current gold standard in the endoscopic management of anastomotic leaks seems to be the usage of self-expanding metal stents (SEMS), with success rates of approximately 70–81%
Aim and design of the study The aim of the open, randomized ESOLEAK study is to investigate in a prospective manner two different endoscopic treatment modalities of anastomotic leakages after Ivor Lewis esophagectomy, namely the endoscopic placement of self-expanding metal stents (SEMS) and the endoscopic vacuum therapy (EVT)
Summary
Intrathoracic 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). An increasing number of patients has been treated with this method showing promising results in retrospective studies: The healing rates range between 67 and 100% [11,12,13,14,15,16,17,18] Both treatment strategies present advantages and drawbacks: While SEMS provide a complete seal of the leak and maintain the esophageal passage for oral intake, they might induce ischemia and require the placement of additional drainages in some of the patients. Endoscopic vacuum therapy offers continuous fluid collection facilitating the granulation process and reducing bacterial proliferation, but needs to be changed every 2–5 days, requires a trans-nasal suction drainage, and forbids oral nutrition [19, 20]
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