A Multicenter, Prospective, Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Safety of Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 438
- 试验地点
- 1
- 主要终点
- Improvement rate of intestinal mucosal clarity after rinsing
研究概览
简要总结
Pronase is a proteolytic enzyme known for its ability to clear mucus by breaking down its main component, mucin, through enzymatic hydrolysis. This property makes it useful in gastroscopy, where it is employed to improve the visibility of the mucosal surface during endoscopic examinations. Given the same mechanism, pronase may also be beneficial in enhancing mucosal clarity during colonoscopy. This multicenter, prospective, double-blind randomized controlled trial is designed to assess the effectiveness and safety of pronase in improving mucosal visibility in patients with colitis during endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with intestinal inflammation during colonoscopy, accompanied by mucus obscuring visualization, were included, particularly those with inflammatory bowel disease (IBD), regardless of the presence or absence of clinical symptoms such as abdominal pain, diarrhea, hematochezia, or mucoid stools.
- •Researchers assessed the current health status of potential participants to ensure they could tolerate colonoscopy (based on physical examination and medical history).
- •Age range was 18-75 years (inclusive).
- •Participants provided written informed consent to participate voluntarily.
排除标准
- •Participants with known hypersensitivity or allergy to the study medication.
- •Participants with peritonitis, intestinal obstruction, severe intestinal infection, or radiation colitis.
- •Participants who did not exhibit intestinal mucus obscuring endoscopic visualization during colonoscopy.
- •Participants with severe cardiovascular, pulmonary, neurological, or renal disease, or those deemed unfit for colonoscopy.
- •Participants who did not provide written informed consent or lacked the capacity to do so.
- •Pregnant or breastfeeding women.
- •Participants who had taken antiplatelet medications (e.g., aspirin, clopidogrel) or had abnormal coagulation function within 7 days prior to colonoscopy.
- •Participants currently participating in other clinical observation trials or who had participated in another clinical trial within 60 days.
研究组 & 干预措施
Pronase Group (Group A)
During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus.
干预措施: Pronase (Drug)
Saline Group (Group B)
During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Improvement rate of intestinal mucosal clarity after rinsing
时间窗: From the start of the rinse to 30 seconds after the end of the rinse.
This is defined as a mucosal clarity improvement score of 3 or higher on colonoscopy after rinsing of the mucoid attachment site, signifying achievement of mucosal clarity improvement. The improvement rate is calculated as the percentage of participants within a group who achieve mucosal clarity improvement divided by the total number of participants in that group.
次要结局
- Colonoscopist satisfaction score(From start to finish of the colonoscopy.)
- Rinsing solution volume(From the start of the rinse to 30 seconds after the end of the rinse.)
- Ulcerative colitis endoscopic index of severity，UCEIS(From the start of the rinse to 30 seconds after the end of the rinse.)
- Endoscopic severity index of Crohn's disease, CDEIS(From the start of the rinse to 30 seconds after the end of the rinse.)
- Simplified Geboes Score, SGS(From the start of the rinse to 30 seconds after the end of the rinse.)
- Colonic and ileal global histologic disease activity scores, CGHAS(From the start of the rinse to 30 seconds after the end of the rinse.)
研究者
Zhaoshen Li
Director of Gastroenterology Dept and Digestive Endoscopy Center
Changhai Hospital