Evidence map›Paper›PMID 35451010›Full record

ArticleBJS open2022

Eso-Sponge® for anastomotic leakage after oesophageal resection or perforation: outcomes from a national, prospective multicentre registry.

Florian Richter, Alexander Hendricks, Bodo Schniewind, Jochen Hampe, Nils Heits, Witigo von Schönfels, Benedikt Reichert, Katrin Eberle, Mark Ellrichmann, Petra Baumann and 3 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in BJS open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02662777 (International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT02662777 completednot on this map

International, Prospective, Multicenter Registry Designed to Collect Clinical Evidence for Endoscopic Vacuum Treatment Using Eso-SPONGE® for Anastomotic Leakage After Esophageal Resection or Iatrogenic or Spontaneous Esophageal Perforation.

Typeobservational_patient_registrySponsorAesculap AGRan2015 to 2023Enrolled108ConditionsLeakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the EsophagusArmsEso-SPONGE® vacuum treatment
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Endoscopic vacuum therapy.iGIE : innovation, investigation and insights · 2024
    Article
  9. Article
  10. Article
  11. Management and outcomes in a consecutive series of patients with aero-digestive fistula at a tertiary gastro-esophageal surgery center.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2024
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  12. Article
  13. Article
  14. Article
  15. Review
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  17. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Florian RichterDepartment of General, Visceral-, Thoracic-, Transplantation- and Paediatric Surgery, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.ORCID 0000-0001-6190-9259
Alexander HendricksDepartment of General Surgery, University Hospital Rostock, Rostock, Germany.
Bodo SchniewindDepartment of General Surgery and Thoracic Surgery, Hospital of Lueneburg, Lueneburg, Germany.
Jochen HampeMedical Department I, University Hospital Dresden, TU Dresden, Dresden, Germany.
Nils HeitsDepartment of General, Visceral-, Thoracic-, Transplantation- and Paediatric Surgery, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
Witigo von SchönfelsDepartment of General, Visceral-, Thoracic-, Transplantation- and Paediatric Surgery, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
Benedikt ReichertDepartment of General, Visceral-, Thoracic-, Transplantation- and Paediatric Surgery, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
Katrin EberleDepartment of Internal Medicine, Gastroenterology, Sophien-u. Hufeland Hospital, Weimar, Germany.
Mark EllrichmannDepartment of Internal Medicine I, University Medical Centre Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.ORCID 0000-0002-5817-5589
Petra BaumannAesculap AG, Medical Scientific Affairs, Tuttlingen, Germany.
Jan-Hendrik EgbertsDepartment of Surgery, Israelitisches Krankenhaus, Hamburg, Germany.
Thomas BeckerDepartment of General, Visceral-, Thoracic-, Transplantation- and Paediatric Surgery, University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.
Clemens SchafmayerDepartment of General Surgery, University Hospital Rostock, Rostock, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnastomotic leakage (AL) after oesophagectomy and oesophageal perforations are associated with significant morbidity and mortality. Minimally invasive endoscopy is often used as first-line treatment, particularly endoluminal vacuum therapy (EVT). The aim was to assess the performance of the first commercially available endoluminal vacuum device (Eso-Sponge®) in the management of AL and perforation of the upper gastrointestinal tract (GIT).

methodsThe Eso-Sponge® registry was designed in 2014 as a prospective, observational, national, multicentre registry. Patients were recruited with either AL or perforation within the upper GIT. Data were collected with a standardized form and transferred into a web-based platform. Twenty hospitals were enrolled at the beginning of the study (registration number NCT02662777; http://www.clinicaltrials.gov). The primary endpoint was successful closure of the oesophageal defect.

resultsEleven out of 20 centres recruited patients. A total of 102 patients were included in this interim analysis; 69 patients with AL and 33 with a perforation were treated by EVT. In the AL group, a closure of 91 per cent was observed and 76 per cent was observed in the perforation group. The occurrence of mediastinitis (P = 0.002) and the location of the defect (P = 0.008) were identified as significant predictors of defect closure.

conclusionsThe Eso-Sponge® registry offers the opportunity to collate data on EVT with a uniform, commercially available product to improve standardization. Our data show that EVT with the Eso-Sponge® is an option for the management of AL and perforation within the upper GIT.

Indexed as

Anastomotic LeakNegative-Pressure Wound TherapyEndoscopy, GastrointestinalEsophagectomyHumansProspective StudiesRegistries

Identifiers

PMID35451010
PMCPMC9023777

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.