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| Name | Class |
|---|---|
| Affiliated Hospital of Jiangnan University | OTHER |
| The Affiliated People's Hospital of Ningbo University | OTHER_GOV |
| Shanghai 8th People's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pronase Group (Group A) | Experimental | During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus. |
|
| Saline Group (Group B) | Placebo Comparator | During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pronase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of intestinal mucosal clarity after rinsing | 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. | From the start of the rinse to 30 seconds after the end of the rinse. |
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopist satisfaction score | 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. | From start to finish of the colonoscopy. |
| Rinsing solution volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huan-Wei Zhang | Contact | 86-19921942094 | zhanghuanwei@smmu.edu.cn | |
| Yu Bai, MD | Contact | 86-021-31161335 | baiyu1998@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhao-Shen Li, MD, PhD | Changhai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital, Naval Medical University | Shanghai | Shanghai Municipality | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12170403 | Background | Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. doi: 10.1055/s-2002-33220. | |
| 21963063 | Background | Han JP, Hong SJ, Moon JH, Lee GH, Byun JM, Kim HJ, Choi HJ, Ko BM, Lee MS. Benefit of pronase in image quality during EUS. Gastrointest Endosc. 2011 Dec;74(6):1230-7. doi: 10.1016/j.gie.2011.07.044. Epub 2011 Oct 1. |
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| ID | Term |
|---|---|
| D003092 | Colitis |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D011402 | Pronase |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Huashan Hospital |
| OTHER |
| Shanghai Baoshan District Wusong Central Hospital | UNKNOWN |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Pudong Hospital | OTHER |
| The People's Hospital of Leshan | OTHER |
| Shanghai Pudong New Area Gongli Hospital | OTHER |
| Huadong Hospital | OTHER |
| Shanghai Songjiang District Central Hospital | UNKNOWN |
| Jinshan Hospital Fudan University | OTHER |
| Dongfang Hospital Affiliated to Tongji University | OTHER |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
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|
| Saline (NaCl 0,9 %) (placebo) | Drug | 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. |
|
This is defined as the volume of liquid consumed during rinsing of the area with the most severe mucosal mucus adhesion in each case. |
| From the start of the rinse to 30 seconds after the end of the rinse. |
| Ulcerative colitis endoscopic index of severity，UCEIS | 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. | From the start of the rinse to 30 seconds after the end of the rinse. |
| Endoscopic severity index of Crohn's disease, CDEIS | 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. | From the start of the rinse to 30 seconds after the end of the rinse. |
| Simplified Geboes Score, SGS | 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. | From the start of the rinse to 30 seconds after the end of the rinse. |
| Colonic and ileal global histologic disease activity scores, CGHAS | 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. | From the start of the rinse to 30 seconds after the end of the rinse. |
| D007410 |
| Intestinal Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D012697 | Serine Endopeptidases |
| D045726 | Metalloproteases |
| D057057 | Serine Proteases |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |