NCT07198945Enrolling By Invitation不适用
Six Versus Twelve Month SurveillAnce Following Resection of Nonpedunculated ColorectaL Polyps 20-50 mm IN Size Without High Grade Dysplasia (HGD)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 546
- 试验地点
- 10
- 主要终点
- Rate of recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
12-month follow-up
Experimental
Patients will be recommended to complete their first surveillance procedure 12 months after the large polyp removal procedure in order to assess whether the polyp grew back.
干预措施: 12-month follow-up (Procedure)
6-month follow-up
Experimental
Patients will be recommended to complete their first surveillance procedure 6 months after the large polyp removal procedure in order to assess whether the polyp grew back.
干预措施: 6-month follow-up (Procedure)
结局指标
主要结局
Rate of recurrence
时间窗: 1 day
Rate of recurrence will be assessed by identification of recurrent polyp tissue at the follow-up procedure.
次要结局
- Patient Survey Results(Typically 1 to 14 days after the large polyp removal procedure)
- Time of endoscopic management of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Perceived difficulty of endoscopic treatment of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Rate of malignancy identified at first surveillance colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Size of recurrent polyp at first surveillance colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Number of distinct areas of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Rate of high grade dysplasia identified in recurrent polyp(After surveillance colonoscopy, typically 6 months to 12 months)
- Need for surgical intervention to treat recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Types of recurrences at follow-up(At first surveillance colonoscopy, typically 6 months to 12 months)
- Techniques used to treat recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Adverse events that occur after the follow-up procedure(30 days after first surveillance colonoscopy)
- Distance patient travelled to the endoscopy unit(At first surveillance colonoscopy, typically 6 months to 12 months)
- Cost of equipment used at the resection site during the follow-up colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Time of endoscopic management of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Perceived difficulty of endoscopic treatment of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Rate of malignancy identified at first surveillance colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Size of recurrent polyp at first surveillance colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Number of distinct areas of recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Rate of high grade dysplasia identified in recurrent polyp(After surveillance colonoscopy, typically 6 months to 12 months)
- Need for advanced resection techniques to treat recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Patient Survey Results(Typically 1 to 14 days after the large polyp removal procedure)
- Cost of equipment used at the resection site during the follow-up colonoscopy(At first surveillance colonoscopy, typically 6 months to 12 months)
- Need for surgical intervention to treat recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Types of recurrences at follow-up(At first surveillance colonoscopy, typically 6 months to 12 months)
- Adverse events that occur after the follow-up procedure(30 days after first surveillance colonoscopy)
- Techniques used to treat recurrent polyp(At first surveillance colonoscopy, typically 6 months to 12 months)
- Distance patient travelled to the endoscopy unit(At first surveillance colonoscopy, typically 6 months to 12 months)
研究者
John J. Guardiola
Assistant Professor of Clinical Medicine
Indiana University
研究点 (10)
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