Efficacy of the OTSC System in the treatment of GI bleeding and wall defects: a PMCF meta-analysis

Timo Weiland, Sabrina Rohrer, Arthur Schmidt, Edris Wedi, Peter Bauerfeind, Karel Caca, Mouen Khashab, Juergen Hochberger, Franziska Baur, Thomas Gottwald, Marc O. Schurr

Research output: Contribution to journalReview article

Abstract

Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H–mean 93.0% [95%CI 90.2–95.4], AL-mean 89.7% [95%CI 85.9–92.9] and CL-mean 83.8% [95%CI 76.9–89.7]. Pooled durable clinical success proportions were: H-mean 87.5% [95%CI 80.5–93.2], AL-mean 81.4% [95%CI 77.0–85.3] and CL-mean 63.0% [95%CI 53.0–72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.

Original languageEnglish (US)
JournalMinimally Invasive Therapy and Allied Technologies
DOIs
StatePublished - Jan 1 2019

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Fistula
Meta-Analysis
Hemorrhage
Hemostasis
Surgical Instruments
Publications
Therapeutics
Randomized Controlled Trials
Databases
Safety
Research

Keywords

  • clip
  • endoscopic treatment
  • GI hemorrhage
  • GI lesions
  • Meta-analysis

ASJC Scopus subject areas

  • Surgery

Cite this

Efficacy of the OTSC System in the treatment of GI bleeding and wall defects : a PMCF meta-analysis. / Weiland, Timo; Rohrer, Sabrina; Schmidt, Arthur; Wedi, Edris; Bauerfeind, Peter; Caca, Karel; Khashab, Mouen; Hochberger, Juergen; Baur, Franziska; Gottwald, Thomas; Schurr, Marc O.

In: Minimally Invasive Therapy and Allied Technologies, 01.01.2019.

Research output: Contribution to journalReview article

Weiland, Timo ; Rohrer, Sabrina ; Schmidt, Arthur ; Wedi, Edris ; Bauerfeind, Peter ; Caca, Karel ; Khashab, Mouen ; Hochberger, Juergen ; Baur, Franziska ; Gottwald, Thomas ; Schurr, Marc O. / Efficacy of the OTSC System in the treatment of GI bleeding and wall defects : a PMCF meta-analysis. In: Minimally Invasive Therapy and Allied Technologies. 2019.
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abstract = "Since its market launch in 2007, the endoscopic OTSC clipping system has been the object of intensive clinical research. These data were systematically collected for post-market clinical follow-up (PMCF). The aim of the study was the systematic review of the efficacy and safety of the OTSC System. The PMCF database was systematically searched for clinical data on OTSC therapy of GI hemorrhage (H), acute leaks/perforations (AL) and chronic leaks/fistulae (CL). Major outcomes were successful clip application and durable hemostasis/closure of defects. Comprehensive pooled success proportions were established by meta-analytical methods. Four-hundred-fifty-seven publications were reviewed. Fifty-eight articles comprising 1868 patients fulfilled criteria to be included in the analysis. These consisted of retrospective analyses, prospective observational trials, one randomized-controlled trial (STING) and one quasi-controlled study (FLETRock). The pooled proportion analysis revealed high overall proportions of technical success: H–mean 93.0{\%} [95{\%}CI 90.2–95.4], AL-mean 89.7{\%} [95{\%}CI 85.9–92.9] and CL-mean 83.8{\%} [95{\%}CI 76.9–89.7]. Pooled durable clinical success proportions were: H-mean 87.5{\%} [95{\%}CI 80.5–93.2], AL-mean 81.4{\%} [95{\%}CI 77.0–85.3] and CL-mean 63.0{\%} [95{\%}CI 53.0–72.3]. By pooling all clinical data gained, we conclude that OTSC application in GI hemorrhage and closure of GI lesions is safe and effective in real clinical use.",
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AU - Weiland, Timo

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AU - Schmidt, Arthur

AU - Wedi, Edris

AU - Bauerfeind, Peter

AU - Caca, Karel

AU - Khashab, Mouen

AU - Hochberger, Juergen

AU - Baur, Franziska

AU - Gottwald, Thomas

AU - Schurr, Marc O.

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