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Gone but not forgotten: expanding the spectrum of ORISE (submucosal lifting agent) associated diagnostic pitfalls and complications
  1. Pooja Dhorajiya1,
  2. Sultan Mahmood2,
  3. Anne Fabrizio3,
  4. Vikram Deshpande4,
  5. Monika Vyas4
  1. 1Department of Pathology, University of Kansas Medical Center, Kansas City, Kansas, USA
  2. 2Department of Gastroenterology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA
  3. 3Department of Surgery, MedStar Georgetown University Hospital, Washington, District of Columbia, USA
  4. 4Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
  1. Correspondence to Dr Monika Vyas, Department of Pathology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; mvyas1{at}bidmc.harvard.edu

Abstract

Aims A synthetic lifting agent, ORISE, used for endoscopic mucosal resections, has been recalled from the market since November 2022 due to clinical complications. Despite this, the impact of ORISE-associated complications is expected to persist in the foreseeable future. We present a large single institutional series of therapeutic resections from patients for whom ORISE was used for initial endoscopic procedures, highlighting the pitfalls and complications associated with its use.

Methods All specimens showing lifting agent granulomata (LAGs) associated with the use of ORISE were identified. The H&E slides were reviewed to define the morphological characteristics and extent of LAG in the intestinal wall and other organs. The clinical impression and gross findings were compared with the final pathological diagnosis.

Results 34 cases (28 resections and 6 repeat endoscopic mucosal resection specimens) showed LAG. On microscopy, 20.5% showed no residual disease, 64.7% also showed residual precursor lesion and 14.7% also showed malignancy. In 64.2% of cases, a mass lesion was seen grossly but no malignancy was identified microscopically. ORISE was present in vascular spaces (n=9), lymph nodes (n=2), other organs such as appendix (n=1) and omentum/peritoneum (n=1). The major discordance between clinical impression (mass/neoplasm) and final pathology (no residual malignancy) was seen in 4/34 (11.8%) cases. LAGs were seen up to 10 months after the use of ORISE in the prior endoscopic procedure.

Conclusion ORISE deposits may mimic residual/disseminated neoplasm and prompt inadvertent changes in surgical decisions. Awareness of this pitfall is essential to prevent unwarranted surgical resections in patients undergoing follow-up for endoscopically resected lesions.

  • GRANULOMA
  • AMYLOID
  • GASTROENTEROLOGY

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Footnotes

  • Handling editor Deepa T Patil.

  • X @Mvgs1706

  • Contributors PD and MV planned and conducted the study and wrote the initial draft of the manuscript. SM, AF and VD helped with analysis and interpretation of the data, provided expert consultation and critical revisions to the manuscript. The guarantor is MV.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests One of the coauthors is an editor (VD) and one coauthor is an editorial board member (MV).

  • Provenance and peer review Not commissioned; externally peer reviewed.