ArticleTrials2021
Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03962244 (Endoscopic Management of ESOphago-gastric Anastomotic LEAKages), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Endoscopic Management of ESOphago-gastric Anastomotic LEAKages (EsoLeak): Stent Therapy Versus Endoscopic Vacuum Therapy
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Endoscopic Treatment Options for Gastrointestinal Leaks.Visceral medicine · 2022Pooled it
- Management of intra-thoracic anastomotic leakages after esophagectomy: updated systematic review and meta-analysis of endoscopic vacuum therapy versus stenting.BMC surgery · 2022Pooled it
- Endoluminal vacuum therapy for upper gastrointestinal leaks: safe, effective and minimally invasive - insights from a retrospective observational study.Surgical endoscopy · 2026Observational
- Stenting Versus Endoscopic Vacuum Therapy for Anastomotic Leakage After Esophago-Gastric Surgery.Journal of clinical medicine · 2025Article
- Comprehensive Umbrella Review of the Management of Esophageal Anastomotic Leaks.Journal of clinical medicine · 2025Review
- VACStent closure of oesophageal defects by covered stent and endoscopic vacuum therapy: initial use and clinical outcomes.Journal of surgical case reports · 2025Article
- [Anastomotic leakage following surgical resection in the upper gastrointestinal tract].Chirurgie (Heidelberg, Germany) · 2024Article
- Endoscopic vacuum therapy.iGIE : innovation, investigation and insights · 2024Article
- VAC-Stent in the Treatment of Post-Esophagectomy Anastomotic Leaks: A New "Kid on the Block" Who Marries the Best of Old Techniques-A Review.Journal of clinical medicine · 2024Review
- [Endoscopic Treatments in Perforation or Fistula in Upper Gastrointestinal Tract].The Korean journal of helicobacter and upper gastrointestinal research · 2024Review
- Endoscopic vacuum therapy versus self-expandable metal stent for treatment of anastomotic leaks < 30 mm following oncologic Ivor-Lewis esophagectomy: a matched case-control study.Surgical endoscopy · 2023Article
- Effects of gastrointestinal endoscopy at different time points on diagnosis and treatment of upper gastrointestinal bleeding in patients with liver cirrhosis.Wideochirurgia i inne techniki maloinwazyjne = Videosurgery and other miniinvasive techniques · 2023Article
- Endoscopic Vacuum Therapy of Upper Gastrointestinal Anastomotic Leaks: How to Deal with the Challenges (with Video).Life (Basel, Switzerland) · 2023Review
- Applications of endoscopic vacuum therapy in the upper gastrointestinal tract.World journal of gastrointestinal endoscopy · 2023Review
- Endoscopic Vacuum Therapy (EVT) versus Self-Expandable Metal Stent (SEMS) for Anastomotic Leaks after Upper Gastrointestinal Surgery: Systematic Review and Meta-Analysis.Life (Basel, Switzerland) · 2023Review
- Endoscopic Management of Postoperative Esophageal and Upper GI Defects-A Narrative Review.Medicina (Kaunas, Lithuania) · 2023Review
- Technical Review on Endoscopic Treatment Devices for Management of Upper Gastrointestinal Postsurgical Leaks.Gastroenterology research and practice · 2023Review
- The Association between Neoadjuvant Radio-Chemotherapy and Prolonged Healing of Anastomotic Leakage after Esophageal Resection Treated with EndoVAC Therapy.Journal of clinical medicine · 2022Article
- Endoscopic vacuum therapy in the upper gastrointestinal tract: when and how to use it.Langenbeck's archives of surgery · 2022Review
- Endoscopic Vacuum Therapy: When and How to Use It?GE Portuguese journal of gastroenterologyReview
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
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. 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 registrationClinicalTrials.gov NCT03962244 . Registered on May 23, 2019. DRKS-ID DRKS00007941.
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