Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection

Официальное название

Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)

Обзор

The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without high grade dysplasia.

Вмешательства

• Процедура 6-month follow-up
  Eligible patients randomized to the 6-month follow-up arm will undergo their first surveillance procedure 6 months after the removal of their large polyp to check for recurrent polyp tissue.
• Процедура 12-month follow-up
  Eligible patients randomized to the 12-month follow-up arm will undergo their first surveillance procedure 12 months after the removal of their large polyp to check for recurrent polyp tissue.

Первичные конечные точки

• Rate of recurrence [Срок оценки: 1 day]

Вторичные конечные точки (12)

• Time of endoscopic management of recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Perceived difficulty of endoscopic treatment of recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Rate of malignancy identified at first surveillance colonoscopy [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Size of recurrent polyp at first surveillance colonoscopy [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Number of distinct areas of recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Rate of high grade dysplasia identified in recurrent polyp [Срок оценки: After surveillance colonoscopy, typically 6 months to 12 months]
• Need for advanced resection techniques to treat recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Need for surgical intervention to treat recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Types of recurrences at follow-up [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Techniques used to treat recurrent polyp [Срок оценки: At first surveillance colonoscopy, typically 6 months to 12 months]
• Patient Survey Results [Срок оценки: Typically 1 to 14 days after the large polyp removal procedure]
• Adverse events that occur after the follow-up procedure [Срок оценки: 30 days after first surveillance colonoscopy]

Критерии участия

Критерии включения

Patient Criteria

• ≥ 18 years of age
• Ability to provide informed consent
• Willing and able to complete one electronic survey
• Presenting for colonoscopy for any indication
• Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments.

Polyp Criteria

• Size 20-50 mm as documented with photo containing open snare of known size as comparison.
• Histology without high grade dysplasia:

• Conventional Adenoma: adenoma with or without villous components
• Serrated: hyperplastic or sessile serrated lesion

Критерии исключения

Patient Criteria

• Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease.
• Patients with a known or suspected diagnosis of any of the following polyposis or non-polyposis syndromes with known genetic mutations:

• Familial Adenomatous Polyposis Syndrome
• MUTYH associated Polyposis Syndrome
• Juvenile Polyposis Syndrome
• Cowden's Syndrome
• Peutz-Jeghers Syndrome
• Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC) or Lynch Syndrome
• Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy
• Patients who have any colorectal cancer by histologic diagnosis at index procedure
• Patients needing a colonoscopy 6 months or sooner for any indication following the index procedure including burden of synchronous disease, inadequate prep to assess for synchronous disease, inadequate prep that precludes resection of index large polyp, or other reason limiting ability to complete full examination of colon at time of resection.
• ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).
• Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy
• Patients with significant acute or chronic medical, neurologic, or illness that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Polyp Criteria

• Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum
• Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)
• A polyp that is classified as a traditional serrated adenoma.
• Polyps with features of invasive cancer
• Polyps that are not able to be removed with standard endoscopic techniques for any reason
• Polyps that are incompletely resected endoscopically at index procedure
• Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 8 центров

• University of Alabama at Birmingham — Birmingham
• University of Colorado — Aurora
• Rush University — Chicago
• Indiana University — Indianapolis
• The University of Kansas Medical Center — Kansas City
• Beth Israel Deaconess Medical Center — Boston
• Henry Ford Hospital — Detroit
• White River Junction VA Medical Center — White River Junction

Канада · 1 центр

• University of British Columbia — Vancouver

Словения · 1 центр

• University Medical Centre Ljubljana — Ljubljana

Публикации

• Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1095-1129. doi: 10.1053/j.gastro.2019.12.018. Epub 2020 Feb 11. No abstract available. PMID 32122632
• Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available. PMID 32044092
• El Rahyel A, Abdullah N, Love E, Vemulapalli KC, Rex DK. Recurrence After Endoscopic Mucosal Resection: Early and Late Incidence, Treatment Outcomes, and Outcomes in Non-Overt (Histologic-Only) Recurrence. Gastroenterology. 2021 Feb;160(3):949-951.e2. doi: 10.1053/j.gastro.2020.10.039. Epub 2020 Oct 29. No abstract available. PMID 33130101
• Tate DJ, Desomer L, Argenziano ME, Mahajan N, Sidhu M, Vosko S, Shahidi N, Lee E, Williams SJ, Burgess NG, Bourke MJ. Treatment of adenoma recurrence after endoscopic mucosal resection. Gut. 2023 Oct;72(10):1875-1886. doi: 10.1136/gutjnl-2023-330300. Epub 2023 Jul 6. PMID 37414440
• Mohapatra S, Almazan E, Charilaou P, et al. Outcomes of Endoscopic Resection for Colorectal Polyps With High-Grade Dysplasia or Intramucosal Cancer. Techniques and Innovations in Gastrointestinal Endoscopy 2023;25:119-126.
• Parsa N, Ponugoti P, Broadley H, Garcia J, Rex DK. Risk of cancer in 10 - 19 mm endoscopically detected colorectal lesions. Endoscopy. 2019 May;51(5):452-457. doi: 10.1055/a-0799-9997. Epub 2019 Jan 8. PMID 30620947
• McWhinney CD, Vemulapalli KC, El Rahyel A, Abdullah N, Rex DK. Adverse events and residual lesion rate after cold endoscopic mucosal resection of serrated lesions >/=10 mm. Gastrointest Endosc. 2021 Mar;93(3):654-659. doi: 10.1016/j.gie.2020.08.032. Epub 2020 Sep 3. PMID 32891621
• Bobay MC, Lahr RE, Shultz J, Vemulapalli KC, Guardiola JJ, Rex DK. Safety of first surveillance colonoscopy at 12 months after piecemeal EMR of large nonpedunculated colorectal lesions. Gastrointest Endosc. 2024 Nov;100(5):905-913. doi: 10.1016/j.gie.2024.05.008. Epub 2024 May 14. PMID 38750975

Идентификаторы

NCT: NCT07198945 · 22913

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗