Colorectal adenomas Adenomatosis (polyposis with dysplasia) Sessile serrated lesions Traditional serrated adenomas Inflammatory bowel disease (IBD)-associated dysplasia
Conditions
Interventions
Subgroup Stratification Based on Bowel Preparation Quality:None
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female aged between 40 and 75 years; 2.Subjects scheduled to undergo colonoscopy; 3.Willing to cooperate with the investigator and comply with all study requirements,Signed written informed consent obtained prior to inclusion in the study;
Exclusion criteria
Exclusion criteria: 1.Patients with any of the following high-risk factors for colorectal cancer: history of colorectal cancer, previous diagnosis of inflammatory bowel disease (IBD), serrated polyposis syndrome (SPS), familial adenomatous polyposis (FAP), or a first-degree relative with a history of colorectal cancer (including both non-hereditary and hereditary familial history of colorectal cancer); 2.Female patients who are pregnant or breastfeeding, or male patients whose spouses have pregnancy plans within the next 3 months; 3.History or suspicion of allergy to methylene blue or its components; 4.History or suspicion of allergy to polyethylene glycol (PEG) and/or other components of bowel preparation agents; 5.History of gastrointestinal obstruction or perforation, toxic megacolon, colectomy, diverticulitis (with risk of perforation during colonoscopy), heart failure (NYHA Class III or IV), or severe cardiovascular disease; 6.Presence of liver disease with coagulopathy (activated partial thromboplastin time exceeding 1.5 times the upper limit of normal); 7.Active gastrointestinal bleeding (including melena or hematochezia) requiring hospitalization or blood transfusion; 8.Known or suspected glucose-6-phosphate dehydrogenase (G6PD) deficiency; 9.Known or suspected deficiency of NADPH-dependent reductase; 10.Concomitant or prior treatment within the past 2 weeks with any medications that may interact with methylene blue (see list of prohibited drugs), including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or monoamine oxidase A inhibitors; 11.Participation in any other clinical trial within 30 days prior to enrollment or current enrollment in another clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Right colon precancerous lesion detection rate during colonoscopy; | — |
Countries
China
Contacts
Public ContactLu Li
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed