6-year Follow-up Data After the Berberine Intervention Trial

Recruiting

• Conditions: Colorectal Adenoma; Colorectal Cancer Control and Prevention; Colorectal Polyps
• Interventions: Drug: Berberine Hydrochloride; Drug: Placebo

• Registration Number: NCT06629051
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Colorectal cancer (CRC) is a common malignancy of the digestive tract, which constitutes a major public health burden. Almost 90% of CRC cases progress from precursor adenomatous polyps through adenoma-carcinoma sequence. Endoscopic detection and removal of colorectal adenoma (CRA) could reduce the incidence and mortality risk of CRC, but the recurrence rate is still high. Therefore, chemoprevention is quite important, not only solve the urgent public health problem, but also be cost-effective.

In 2020, the investigators published a multicenter, randomized, double-blind, placebo-controlled clinical study (NCT02226185) in the Lancet Gastroenterology \& Hepatology. The result concluded that oral BBR for 2 years significantly reduced recurrence after endoscopic removal of CRA (RR 0.77, 95%CI 0.66-0.91; p=0.001). BBR also has a significant preventive effect on all polypoid lesions, including adenomas and serrated lesions (adjusted RR 0.78, 95%CI 0.66-0.91; p=0.002) . Does BBR still have a long-term protective effect on the recurrence of CRA after discontinuation? That's what the investigators concerned.

The present study is performed to observe and compare retrospectively the recurrence rate of CRAs in patients of the original BBR RCT study (NCT02226185) within 6 years after discontinuation of medication, including the overall recurrence rate of traditional adenomas within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years. The aim is to evaluate the long-term efficacy of BBR in preventing recurrence and carcinogenesis after endoscopic resection of CRAs.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study Start: 2024-10-04
• Study First Submitted QC: 2024-10-04
• Last Update Submitted: 2024-10-04
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 891

Inclusion Criteria

participants who completed the previous berberine intervention study (NCT02226185)

Exclusion Criteria

no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
berberine	Berberine Hydrochloride	post-intervention of berberine
placebo	Placebo	post-intervention of placebo tablets

Primary Outcome Measures

Name	Time	Method
The recurrence rates of traditional colorectal adenomas within the follow-up period of 6 years	6 years, 1-3 years, 3-6 years	The cumulative recurrence rate of CRAs within the entire follow-up period of 6 years. The recurrence rates of CRAs within the first year, 1-3 years, 3-6 years. The number, size and location of all adenomas are assessed.

Secondary Outcome Measures

Name	Time	Method
The incidence rates of hyperplastic polyps and serrated adenomas within 6 years after discontinuation of medication	6 years, 1-3 years, 3-6 years	The recurrence rates within the first year, 1-3 years, 3-6 years, and the entire follow-up period of 6 years.
Subgroup analyses	6 years, 1-3 years, 3-6 years	For patients with advanced CRA or high-risk adenomas (including advanced CRA and multiple adenomas≥3），the recurrence rates of CRAs and polyps are further evaluated.

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, China