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

Official title

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

Overview

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

• 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, t
• 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

Primary outcome measures

• Improvement rate of intestinal mucosal clarity after rinsing [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]

Secondary outcome measures (6)

• Colonoscopist satisfaction score [Time frame: From start to finish of the colonoscopy.]
• Rinsing solution volume [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]
• Ulcerative colitis endoscopic index of severity，UCEIS [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]
• Endoscopic severity index of Crohn's disease, CDEIS [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]
• Simplified Geboes Score, SGS [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]
• Colonic and ileal global histologic disease activity scores, CGHAS [Time frame: From the start of the rinse to 30 seconds after the end of the rinse.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Diagnostic

Study locations

China · 1 center

• Changhai Hospital, Naval Medical University — Shanghai

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. PMID 12170403
• 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. PMID 21963063

Identifiers

NCT: NCT06874673 · CHEC2024-330

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗