Dataset Information

Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial.

ABSTRACT:

Background

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). 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.

Methods

This 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.

Discussion

The 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 registration

ClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.

SUBMITTER: Tachezy M

PROVIDER: S-EPMC8170795 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionGastric leaks constitute some of the most severe complications after obesity surgery. Resulting peritonitis can lead to inflammatory changes of the stomach wall and might necessitate drainage. The inflammatory changes make gastric leak treatment difficult. A common endoscopic approach of using stents causes the problem of inadequate leak sealing and the need for an external drainage. Based on promising results using endoscopic vacuum therapy (EVT) for esophageal leaks, we implemented this concept for gastric leak treatment after bariatric surgery (Ahrens et al., Endoscopy 42(9):693-698, 2010; Schniewind et al., Surg Endosc 27(10):3883-3890, 2013).MethodsWe retrospectively analyzed data of 31 gastric leaks after bariatric surgery. For leak therapy management, we used revisional laparoscopy with suturing and drainage. EVT was added for persistent leaks in sixteen cases and was used in four cases as standalone therapy.ResultsTwenty-one gastric leaks occurred in 521 sleeve gastrectomies (leakage rate 4.0%), 9 in 441 Roux-en-Y gastric bypasses (leakage rate 2.3%), and 1 in 12 mini-bypasses. Eleven of these gastric leaks were detected within 2 days after bariatric surgery and successfully treated by revision surgery. Sixteen gastric leaks, re-operated later than 2 days, remained after revision surgery, and EVT was added. Without revision surgery, we performed EVT as standalone therapy in 4 patients with late gastric leaks. The EVT healing rate was 90% (18 of 20). In 2 patients with a late gastric leak in sleeve gastrectomy, neither revisional surgery, EVT, nor stent therapy was successful. EVT patients showed no complications related to EVT during follow-up.ConclusionEVT is highly beneficial in cases of gastric leaks in obesity surgery where local peritonitis is present. Revisional surgery was unsuccessful later than 2 days after primary surgery (16 of 16 cases). EVT shows a similar healing rate to stent therapy (80-100%) but a shorter duration of treatment. The advantages of EVT are endoscopic access, internal drainage, rapid granulation, and direct therapy control. In compartmentalized gastric leaks, EVT was successful as a standalone therapy without external drainage.