Trans-nasal Endoscopy for Bariatric Patients

Официальное название

Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program

Обзор

This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.

Подробное описание

Oral sedated endoscopy of the upper gastrointestinal tract as Esophagogastroduodenoscopy (EGD) has been time tested and effective, but poses enhanced risk in the bariatric population. In the adult population nasal rather than orally guided EGD is available without sedations. This is known as transnasal endoscopy (TNE). Adult studies have demonstrated its feasibility, more rapid implementation, a possibility for increased endoscopy access, and enhanced safety for its use in multiple upper gastrointestinal tract disease, however it has not been readily adopted in the United States using standard 5-6 mm transnasal endoscopes.

Generally, having only sedated oral upper tract endoscopy using a typical 9-10 mm endoscope available in the United States has created problems with increasing costs, delayed diagnosis, endoscopy access issues, and morbidity around upper gastrointestinal tract disease. In a bariatric and metabolic program this can also delay care and timely intervention to allow for weight loss and improved morbidity. The recent COVID-19 pandemic has also hindered access to general diagnostic endoscopy and the referrals from bariatric programs could also prevent access for other general diagnostic screening or surveillance endoscopy not in the bariatric population. Additionally, the total cost of a sedated EGD can exceed $10,000 due to the cost of anesthesia. In high-risk populations such as the elderly and individuals with increased body mass index (BMI), the use of endotracheal tubes and deep sedation can lead to aspiration, atelectasis, or pneumonia. Most recently Friedlander and Nguyen et al published reports on the increased use of sedation-free endoscopy using even smaller endoscopes for primarily Eosinophilic esophagitis (EoE) but also a variety of diseases. Additionally, DeBoer et al published on the use of TNE in bariatric endoscopic screening and showed success and lower costs in an adult population. EvoEndo, Inc. has developed and introduced an FDA cleared 3.5 mm, portable, single-use endoscopy system that enables transnasal endoscopy of the upper GI tract with mucosal biopsies. It has the potential to more broadly introduce enhanced sedation-free endoscopic options for high risk patients in need of endoscopic screening for bariatric conditions in the United States. This study aims to evaluate the introduction of sedation-free TNE to an ambulatory bariatric clinic and evaluate its impact on time to diagnosis, time to intervention, impact on patient (direct/indirect) and clinic costs (direct/indirect) and revenue and the provider/team experience introducing the system.

Вмешательства

• Устройство Transnasal Endoscopy
  Unsedated endoscopic evaluation through the nose.
• Процедура Esophagogastroduodenoscopy
  Sedated endoscopic evaluation through the mouth.

Первичные конечные точки

• Experience survey [Срок оценки: Up to 7 days post procedure]

Вторичные конечные точки (9)

• Patient interest [Срок оценки: Baseline]
• Patient satisfaction - mGHAA-9 [Срок оценки: Up to 7 days post procedure]
• Patient satisfaction - TNE Post-procedure evaluation [Срок оценки: Up to 7 days post procedure]
• Duration of procedure [Срок оценки: Up to 7 days post procedure]
• Total Endoscopy Experience duration [Срок оценки: Up to 7 days post procedure]
• Time to diagnosis [Срок оценки: Baseline, Up to 30 days post procedure]
• Biopsy sample adequacy [Срок оценки: Up to 30 days post procedure]
• Comparison of cost of TNE versus EGD [Срок оценки: Up to 30 days post procedure]
• Adverse Events [Срок оценки: Up to 30 days post procedure]

Критерии участия

Критерии включения

• Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)
• Cared for in metabolic and bariatric clinic

Критерии исключения

• Patient <18 years of age
• Medically contraindicated to perform EGD or TNE
• Inability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Публикации

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• American Societyfor Gastrointestinal Endoscopy Standards of Practice Committee; Evans JA, Muthusamy VR, Acosta RD, Bruining DH, Chandrasekhara V, Chathadi KV, Eloubeidi MA, Fanelli RD, Faulx AL, Fonkalsrud L, Khashab MA, Lightdale JR, Pasha SF, Saltzman JR, Shaukat A, Wang A, Stefanidis D, Richardson WS, Kothari SN, Cash BD. The role of endoscopy in the bariatric surgery patient. Gastrointest Endo PMID 25733126
• Kolb JM, Han S, Scott FI, Murphy CC, Hosokawa P, Wani S; Early Onset Esophageal Adenocarcinoma Study Group. Early-Onset Esophageal Adenocarcinoma Presents With Advanced-Stage Disease But Has Improved Survival Compared With Older Individuals. Gastroenterology. 2020 Dec;159(6):2238-2240.e4. doi: 10.1053/j.gastro.2020.08.002. Epub 2020 Aug 8. No abstract available. PMID 32777286
• Thrift AP. Barrett's Esophagus and Esophageal Adenocarcinoma: How Common Are They Really? Dig Dis Sci. 2018 Aug;63(8):1988-1996. doi: 10.1007/s10620-018-5068-6. PMID 29671158
• Rubenstein JH, Shaheen NJ. Epidemiology, Diagnosis, and Management of Esophageal Adenocarcinoma. Gastroenterology. 2015 Aug;149(2):302-17.e1. doi: 10.1053/j.gastro.2015.04.053. Epub 2015 May 7. PMID 25957861
• Shaheen NJ, Falk GW, Iyer PG, Souza RF, Yadlapati RH, Sauer BG, Wani S. Diagnosis and Management of Barrett's Esophagus: An Updated ACG Guideline. Am J Gastroenterol. 2022 Apr 1;117(4):559-587. doi: 10.14309/ajg.0000000000001680. PMID 35354777
• ASGE STANDARDS OF PRACTICE COMMITTEE; Qumseya B, Sultan S, Bain P, Jamil L, Jacobson B, Anandasabapathy S, Agrawal D, Buxbaum JL, Fishman DS, Gurudu SR, Jue TL, Kripalani S, Lee JK, Khashab MA, Naveed M, Thosani NC, Yang J, DeWitt J, Wani S; ASGE Standards of Practice Committee Chair. ASGE guideline on screening and surveillance of Barrett's esophagus. Gastrointest Endosc. 2019 Sep;90(3):335-359.e PMID 31439127

Идентификаторы

NCT: NCT06200961 · 2023P002683

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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