Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pronase; Mucosal Clarity
• Intervention / Treatment: Drug: Pronase; Drug: Saline (NaCl 0,9 %) (placebo)

• Study Type: Interventional
• Enrollment (Estimated): 438
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Bai, MD; Phone Number: 86-021-31161335; Email: baiyu1998@hotmail.com
• Study Contact Backup: Name: Huan-Wei Zhang; Phone Number: 86-19921942094; Email: zhanghuanwei@smmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Changhai Hospital, Naval Medical University
      • Contact: Huan-Wei Zhang; Phone Number: +86-19921942094; Email: zhanghuanwei@smmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pronase Group (Group A); During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus.	Drug: Pronase; 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.
Placebo Comparator: Saline Group (Group B); During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus.	Drug: Saline (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Huashan Hospital; Affiliated Hospital of Jiangnan University; Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai Pudong Hospital; The Affiliated People's Hospital of Ningbo University; Jinshan Hospital Fudan University; The People's Hospital of Leshan; Shanghai Songjiang District Central Hospital; Huadong Hospital; Dongfang Hospital Affiliated to Tongji University; Shanghai Pudong New Area Gongli Hospital; Shanghai 8th People's Hospital; Shanghai Baoshan District Wusong Central Hospital
• Investigators: Study Chair: Zhao-Shen Li, MD, PhD, Changhai Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 17, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Colonoscopy; Crohn's Disease; inflammatory bowel disease; Colitis; Pronase; Mucosal Clarity
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Colitis
• Other Study ID Numbers: CHEC2024-330

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No