Colorectal Adenoma, Colorectal Cancer Control and Prevention, Colorectal Polyps
Conditions
Keywords
berberine, colorectal adenoma, colorectal cancer, long term chemoprevention, colorectal polyps
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.
Interventions
post-intervention of berberine
DRUGPlacebo
Looks the same as berberine
Sponsors
Seventh Medical Center of PLA Army General Hospital
Zhongshan Hospital Xiamen University
Nanfang Hospital, Southern Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Tianjin Medical University General Hospital
the Tenth People's Hospital affiliated to Tongji University
Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
participants who completed the previous berberine intervention study (NCT02226185)
Exclusion criteria
no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactJing-Yuan Fang, Professor
Outcome results
None listed