Mucosal Clarity, Pronase
Conditions
Keywords
Pronase, Colonoscopy, Mucosal Clarity, Colitis, Ulcerative Colitis, Crohn's Disease, inflammatory bowel disease
Brief summary
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.
Interventions
DRUGPronase
During the colonoscopy procedure on participants in Group A, when colitis with mucosal mucus impeding visualization is encountered, the gastroenterologist uses a solution of pronase (200 U/mL) delivered through the endoscope's biopsy forceps to irrigate the affected area. Images are captured before and after the irrigation, and a score for improvement in mucosal clarity is assigned. The location of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.
DRUGSaline (NaCl 0,9 %) (placebo)
During the colonoscopy procedure on participants in Group B, when colitis with mucosal mucus impeding visualization is encountered, the gastroenterologist uses saline delivered through the endoscope's biopsy forceps to irrigate the affected area. Images are captured before and after the irrigation, and a score for improvement in mucosal clarity is assigned. The location of the lesion, irrigation time, and volume of fluid used are recorded. During endoscope withdrawal, the same area is reassessed for improvement in clarity, and the disease activity is evaluated. Biopsy specimens are taken from the most severe inflammation site for histopathological examination.
Sponsors
Affiliated Hospital of Jiangnan University
The Affiliated People's Hospital of Ningbo University
Shanghai 8th People's Hospital
Huashan Hospital
Shanghai Baoshan District Wusong Central Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Pudong Hospital
The People's Hospital of Leshan
Shanghai Pudong New Area Gongli Hospital
Huadong Hospital
Shanghai Songjiang District Central Hospital
Jinshan Hospital Fudan University
Dongfang Hospital Affiliated to Tongji University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement rate of intestinal mucosal clarity after rinsing | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rinsing solution volume | From the start of the rinse to 30 seconds after the end of the rinse. | This is defined as the volume of liquid consumed during rinsing of the area with the most severe mucosal mucus adhesion in each case. |
| Ulcerative colitis endoscopic index of severity，UCEIS | From the start of the rinse to 30 seconds after the end of the rinse. | The UCEIS score is a standardized tool for assessing the severity of inflammation in ulcerative colitis (UC) based on three core features: vascular Pattern, bleeding, and erosions/ulcers, as viewed through enteroscopy, with a total score of 0-8, with higher scores suggesting more severe lesions. |
| Colonoscopist satisfaction score | From start to finish of the colonoscopy. | This reflects the overall satisfaction of the colonoscopist with the effect of the rinsing solution on mucosal clarity, measured using a 5-point Likert scale.Scores range from 5 to 1, with higher scores meaning better results. |
| Simplified Geboes Score, SGS | From the start of the rinse to 30 seconds after the end of the rinse. | The Simplified Geboes Score evaluates the degree of tissue inflammation by assessing neutrophils in the lamina propria, neutrophils in the epithelium and epithelial damage in the crypts and mucosal surfaces. The scale is as follows: grade 0 represents structural abnormalities or chronic infiltration without active inflammation; grade 1 represents basal plasmacytosis; grade 2 represents inflammatory cell infiltration in the lamina propria; grade 3 represents neutrophil infiltration in the epithelium; grade 4 represents crypt epithelial damage and grade 5 represents surface epithelial damage. |
| Colonic and ileal global histologic disease activity scores, CGHAS | From the start of the rinse to 30 seconds after the end of the rinse. | The CGHAS scoring system evaluates mucosal inflammation levels in Crohn's disease patients through histological assessment of mucosal tissue biopsies. Its assessment parameters include: lamina propria inflammatory cell infiltration (e.g., neutrophils, mononuclear cells); chronic structural damage (e.g., crypt distortion, glandular architectural disarray); epithelial injury (e.g., erosions, ulcerations); and the extent of lesion involvement (quantified by the number of affected biopsy specimens). The scoring scale ranges from 0 to 16 points, with higher scores indicating more severe inflammatory activity. |
| Endoscopic severity index of Crohn's disease, CDEIS | From the start of the rinse to 30 seconds after the end of the rinse. | The CDEIS is based on the assessment of 4 parameters (deep ulcers, shallow ulcers, extent of surface involvement, and extent of ulcer involvement) in 5 sites (terminal ileum, right hemicolon, transverse colon, left hemisphere and sigmoid colon, and rectum), and the total score for an individual segment divided by the number of segments assessed, plus the presence or absence of stenosis yields a total score that ranges from 0 \ 44 points, with higher scores suggestive of more severe lesions. |
Countries
China
Contacts
Primary ContactHuan-Wei Zhang
Backup ContactYu Bai, MD
Outcome results
None listed