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

Indiana University

Status: Not yet enrolling

Conditions: Recurrence, Local Neoplasm; Colon Cancer; Endoscopic Resection; Serrated Polyp; Colon Polyp; Adenoma

Treatments: Procedure: 12-month follow-up; Procedure: 6-month follow-up

Study type: Interventional

Funder types: Other

Identifiers

NCT07198945

22913

Details and patient eligibility

About

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.

Enrollment: 546 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patient Criteria

1. ≥ 18 years of age

2. Ability to provide informed consent

3. Willing and able to complete one electronic survey

4. Presenting for colonoscopy for any indication

5. 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

6. Size 20-50 mm as documented with photo containing open snare of known size as comparison.

7. Histology without high grade dysplasia:

   1. Conventional Adenoma: adenoma with or without villous components
   2. Serrated: hyperplastic or sessile serrated lesion

Exclusion criteria

Patient Criteria

1. Patients with confirmed diagnosis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease.

2. 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

3. Patients who have high grade dysplasia found in any polyp ≥ 20 mm removed at the index colonoscopy

4. Patients who have any colorectal cancer by histologic diagnosis at index procedure

5. 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.

6. ASA ≥ 4 or documented coagulopathy or severe thrombocytopenia (INR ≥ 2 or platelets ≤ 20).

7. Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy

8. 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

9. Polyp located at appendiceal orifice, ileocecal valve, or intradiverticulum

10. Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)

11. A polyp that is classified as a traditional serrated adenoma.

12. Polyps with features of invasive cancer

13. Polyps that are not able to be removed with standard endoscopic techniques for any reason

14. Polyps that are incompletely resected endoscopically at index procedure

15. Polyps removed by endoscopic submucosal dissection (ESD) or by full thickness resection device (FTRD)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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546 participants in 2 patient groups

6-month follow-up

Experimental group

Description:

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.

Treatment:

Procedure: 6-month follow-up

12-month follow-up

Experimental group

Description:

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.

Treatment:

Procedure: 12-month follow-up