colonoscopic screening or colonoscopic surveillance for colorectal tumors
Conditions
Interventions
Experimental group :Methylene Blue MMX? tablets 200mg(8 tablets)
Control group :Placebo (8 tablets)
Sponsors
Beijing Friendship Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Males or females, aged between 50 and 75. 2) Women participating in the study should meet these criteria: non-reproductive age women, including women with documented (verified by medical reports) hysterectomy or double oophorectomy or postmenopausal women; Or women of reproductive age who had a negative pregnancy test result at screening and who completely abstained from sexual intercourse or consented to the use of highly effective contraceptive methods during the study period until follow-up procedures were completed; 3) Patients who plan to undergo colonoscopy screening, monitoring, and diagnosis due to gastrointestinal symptoms; - Screening: Patients screened for colorectal tumors, including those who have never had a previous colonoscopy, or Patients who received repeated screening with first colonoscopy results were negative (no adenomatous polyps were detected) and returned within 10 years (=10 years) - Surveillance: includes patients who have had 1 or more adenomatous polyps detected during a previous colonoscopy within the last 10 years; These patients will be further classified as being monitored within 3 years (=3 years) of prior colonoscopy, and 3 to 10 years (> 3 and =10 years) of previous colonoscopy - Diagnosis due to gastrointestinal symptoms: includes patients who undergo diagnostic colonoscopy due to gastrointestinal symptoms such as blood in the stool, constipation, bloating, changes in bowel habits, etc 4) Able to comprehend the full nature and purpose of the study, including possible risks and side effects. 5) Able to co-operate with the investigator and to comply with the requirements of the entire study. 6) Signed written informed consent prior to inclusion in the study
Exclusion criteria
Exclusion criteria: 1) Patients with any of the following risk factors for colorectal cancer: a history of colorectal cancer, a known previous diagnosis of inflammatory bowel disease (IBD), serrated polyposis syndrome (SPS), familial polyposis syndrome (FAP), and a history of colorectal cancer in a first-degree relative (including a family history of nonhereditary colorectal cancer and a family history of hereditary colorectal cancer); 2) The female patient is pregnant or breastfeeding, or the male patient's spouse has a pregnancy plan within the last 3 months; 3) Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients; 4) Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients; 5) Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis with risk of perforation during colonoscopy, or heart failure (Class III or IV), serious cardiovascular disease; 6) According to clinical practice, the investigator determines that the patient needs to undergo colonoscopy random biopsy ; 7) ALT, AST, GGT, Bilirubin, Creatinine or Urea greater than 2.5 x the upper limit for normal range, based on local laboratory testing; 8) The presence of serious cardiovascular disease, including very large abdominal aortic aneurysms(particularly =5 cm in diameter or symptomatic need suigery), patients who are immediately postoperative, and patients who have suffered recent myocardial infarction (within 3 weeks), pulmonary embolism, or are currently hemodynamically unstable. 9) The presence of liver disease with coagulopathy (activating part of thromboplastin for more than 1.5 times the upper limit of normal); 10) Active gastrointestinal bleeding requiring hospitalization or blood transfusion treatment (including melanomia or hematochezia); 11) A history of anaemia (previously recorded haemoglobin of less than 10mg/dL) within the last 30 days prior to enrollment. 12) Known evidence of glucose-6-phosphate deficiency, 13) Known deficiency of NADPH reductase 14) Treatment within 5 weeks prior to randomisation with Fluoxetine. 15) Concurrent treatment, or previous treatment within 2 weeks with any of the prohibited psychiatric medications that may interact with Methylene Blue as listed under Prohibited medications;Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinepherine Reuptake Inhibitors(SNRI’s), listed Tricyclic anti-depressants or Monoamine oxidase A inhibitors. 16) Current enrollment in any other clinical trial, or previous enrollment in a clinical trial within the last 30 days. 17) Other medical condition that in the investigators opinion would make the administration of the study drug or procedures hazardous to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection rate of nonpolypoid colorectal neoplasms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection rate of non-polypoid adenoma;mean number of nonpolypoid colorectal neoplasms;mean number of nonpolypoid adenoma;false positive rate; | — |
Countries
China
Contacts
Public ContactShutian Zhang
Beijing Friendship Hospital,Capital Medical University
Outcome results
None listed