P1832 - A Multicenter Retrospective Evaluation of the Clinical Performance and Safety of an Enhanced 16 Fr CryoDecompression Tube for Use in Liquid Nitrogen Spray Cryotherapy

Award: Presidential Poster Award

Vivek Kaul, MD, FACG¹, Jeremy Barber, DO², Raman Battish, MD³, Walter Coyle, MD⁴, John Dumot, DO⁵, Stuart R. Gordon, MD⁶, Saurabh Gupta, MD⁷, Kunal Jajoo, MD⁸, Shivangi Kothari, MD¹, Shaffer R. S.. Mok, MD⁹, Jacob Moremen, MD¹⁰, Kevin Robillard, MD¹¹, Eric Sceusi, MD¹², Neil R.. Sharma, MD¹³, Michael S.. Smith, MD, MBA¹⁴, Franklin Tsai, MD⁴, John Vargo, MD¹⁵, Pankaj Vashi, MD¹⁶, Eugene Zolotarevsky, MD¹⁷, Bruce Greenwald, MD^18
1University of Rochester, Rochester, NY; ²Corewell Health, Grand Rapids, MI; ³Virtua Health System/Virtua Medical Group, Cherry Hill, NJ; ⁴Scripps Clinic, La Jolla, CA; ⁵University Hospitals Cleveland Medical Center, Cleveland, OH; ⁶Dartmouth-Hitchcock Medical Center, Lebanon, NH; ⁷Sutter Health, San Francisco, CA; ⁸Brigham and Women's Hospital, Boston, MA; ⁹Moffitt Cancer Center, Tampa, FL; ¹⁰University of Mississippi Medical, Jackson, MS; ¹¹Roswell Park Cancer Institute, Buffalo, NY; ¹²Piedmont Heart Institute, Atlanta, GA; ¹³Parkview Cancer Institue, Fort Wayne, IN; ¹⁴Icahn School of Medicine at Mount Sinai, New York, NY; ¹⁵Cleveland Clinic, Cleveland, OH; ¹⁶City of Hope - Chicago, Zion, IL; ¹⁷Corewell Health West, Grand Rapids, MI; ¹⁸University of Maryland, Baltimore, MD

Introduction: Endoscopic liquid nitrogen spray cryotherapy (LNSCT) is an established treatment modality for management of dysplastic Barrett’s esophagus (BE) and esophageal cancer (EC). Placement of an orogastric decompression tube (CDT) is required for active and passive venting of nitrogen gas generated during treatment. Currently available CDTs are limited by size (20 Fr) and soft, flexible material (16 Fr). An enhanced, fluoroscopically visible 16 Fr CDT was developed to maintain luminal patency and rigidity despite a smaller caliber. The aim of this study was to evaluate the performance and safety of this new, FDA-cleared CDT.

Methods: This multicenter retrospective on-label case series was approved by central IRB. All adult patients with dysplastic BE or EC who underwent LNSCT using the enhanced CDT in February/March 2023 were included. Primary outcomes included ease of operation/use, rate of intraprocedural adverse events and rate of uninterrupted procedure completion.

Results: A total of 28 patients (93% male, mean age 67.4 years) from 16 U.S. medical centers met inclusion criteria (Table 1). The most common indication was EC (20, 71.4%). There were 15 patients (57.7%) with a hiatal hernia and 18 patients (64.3%) with luminal stenosis; 3 (10.7%) had narrowing which prohibited endoscope passage. In 12 cases (42.9%), the endoscopist felt a 20Fr CDT could not have been used (due to luminal stenosis). A standard gastroscope was used for most cases (21, 75%). All patients had intraprocedural abdominal monitoring, with only 1 (3.6%) experiencing mild abdominal distension. All procedures were completed successfully without treatment interruption. Tube integrity was maintained in all patients (100%). Compared to the existing/older 16 Fr CDT, most providers rated insertion of this enhanced CDT as easier (24, 87.5%), with easier endoscope maneuverability (26, 92.9%).

Discussion: To date, LNSCT users have had to choose between ease of per-oral CDT insertion and maintenance of adequate decompression during treatment. These data suggest an enhanced 16 Fr CDT is safe, effective and easier to use than the existing (older) 16 Fr CDT. A smaller caliber CDT is especially useful to facilitate treatment in patients with advanced EC, where tumor bulk and luminal stenosis leads to dysphagia. When used in combination with an ultra-thin (5-6 mm diameter) gastroscope, this enhanced CDT could markedly increase the number of EC patients who can receive palliative LNSCT.



Disclosures:


Vivek Kaul, MD, FACG¹, Jeremy Barber, DO², Raman Battish, MD³, Walter Coyle, MD⁴, John Dumot, DO⁵, Stuart R. Gordon, MD⁶, Saurabh Gupta, MD⁷, Kunal Jajoo, MD⁸, Shivangi Kothari, MD¹, Shaffer R. S.. Mok, MD⁹, Jacob Moremen, MD¹⁰, Kevin Robillard, MD¹¹, Eric Sceusi, MD¹², Neil R.. Sharma, MD¹³, Michael S.. Smith, MD, MBA¹⁴, Franklin Tsai, MD⁴, John Vargo, MD¹⁵, Pankaj Vashi, MD¹⁶, Eugene Zolotarevsky, MD¹⁷, Bruce Greenwald, MD¹⁸. P1832 - A Multicenter Retrospective Evaluation of the Clinical Performance and Safety of an Enhanced 16 Fr CryoDecompression Tube for Use in Liquid Nitrogen Spray Cryotherapy, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.