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Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study

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Abstract

Introduction

The over-the-scope clip (OTSC) overcomes limitations of standard clips and achieves a more efficient and reliable hemostasis in non-variceal upper gastrointestinal bleeding (NVUGIB). The study aims to evaluate mortality, rebleeding, and mortality after rebleeding of patients in whom the OTSC was used as the first-line endoscopic treatment (FLET) of NVUGIB.

Patients and methods

In total, 118 patients (FLET cohort) with a median age of 73.5 years (range 29–93 years; mean (±SD) 71.39 ± 12.39 years) were included. The distribution of patients with respect to risk category revealed a median Rockall score of 7 (range 3–10). For hypothesis testing, the FLET cohort was categorized into three risk groups taking into account the Rockall score: low risk [Rockall risk category (RRC ≤3)], moderate risk (RRC 4–7), and high risk (RRC ≥8). Event rates (mortality, rebleeding, and mortality after rebleeding) observed per risk group were compared to predicted event rates (Rockall cohort) using Fisher’s Exact Test.

Results

Primary successful hemostasis (PSH) was achieved in 92.4% either by FLET alone or in combination with an additional hemostasis technique in 1.7% (SCS = secondary clinical success). In 7.5% of the FLET cohort PSH could not be achieved. Compared to RRC prediction, mortality after rebleeding was significantly reduced from 27.9 to 10.9% in the high-risk group (RRC ≥8) treated with FLET (p < 0.011). Furthermore, the occurrence of rebleeding or continued bleeding was significantly lower in the moderate risk group (RRC 4–7) with 4.9% as well as in the high-risk group (RRC ≥8) with 21.4% compared to the Rockall cohort 24.0 and 53.2%, respectively (p < 0.001).

Conclusions

This study shows that OTSC is superior to standard care and FLET reduces significantly rebleeding and rebleeding-associated mortality in NVUGIB. For this reason, OTSC could be the treatment of choice as the first-line treatment as an alternative to standard hemostasis techniques in high-risk patients.

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Abbreviations

FLET:

First-line endoscopic treatment

GI:

Gastrointestinal

NVUGIB:

Non-variceal upper gastrointestinal bleeding

OTSC:

Over-the-scope clip

RRC:

Rockall risk category

TTS:

Through-the-scope

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Acknowledgements

We thank Novineon CRO, Consulting Ltd., and Mr. Weiland & Mrs. Meese for their consulting support of the statistics.

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Authors and Affiliations

  1. Department of Gastroenterology and Gastrointestinal Oncology, University Medical Centre Goettingen, Georg-August-University, Robert-Koch-Straße 40, 37075, Goettingen, Germany

    E. Wedi, C. Jung & S. Orkut

  2. Department of Medicine II, Medical Center, Faculty of Medicine, University of Freiburg, 79106, Freiburg, Germany

    A. Fischer & H. J. Richter-Schrag

  3. Departement of Gastroenterology, Vivantes Klinikum in Friedrichshain, Teaching Hospital of Charité Humboldt University, 10249, Berlin, Germany

    J. Hochberger

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  1. E. Wedi
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  2. A. Fischer
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  3. J. Hochberger
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Correspondence to E. Wedi.

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Disclosures

Edris Wedi, Andreas Fischer, Jürgen Hochberger, Carlo Jung, Sinan Orkut and Hans-Jürgen Richter-Schrag have no conflicts of interest or financial ties to disclose.

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Wedi, E., Fischer, A., Hochberger, J. et al. Multicenter evaluation of first-line endoscopic treatment with the OTSC in acute non-variceal upper gastrointestinal bleeding and comparison with the Rockall cohort: the FLETRock study. Surg Endosc 32, 307–314 (2018). https://doi.org/10.1007/s00464-017-5678-7

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