Clinical trial NCT06874673: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pronase
Mucosal Clarity
Keywords: Pronase
Colonoscopy
Mucosal Clarity
Colitis
Ulcerative Colitis
Crohn&#39;s Disease
inflammatory bowel disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Jiangnan University
name: The Affiliated People's Hospital of Ningbo University
name: Shanghai 8th People's Hospital
name: Huashan Hospital
name: Shanghai Baoshan District Wusong Central Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai Pudong Hospital
name: The People's Hospital of Leshan
name: Shanghai Pudong New Area Gongli Hospital
name: Huadong Hospital
name: Shanghai Songjiang District Central Hospital
name: Jinshan Hospital Fudan University
name: Dongfang Hospital Affiliated to Tongji University
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2025-03-13
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Improvement rate of intestinal mucosal clarity after rinsing
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
Secondary outcomes:
measure: Colonoscopist satisfaction score
timeFrame: From start to finish of the colonoscopy.
measure: Rinsing solution volume
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
measure: Ulcerative colitis endoscopic index of severity，UCEIS
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
measure: Endoscopic severity index of Crohn's disease, CDEIS
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
measure: Simplified Geboes Score, SGS
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
measure: Colonic and ileal global histologic disease activity scores, CGHAS
timeFrame: From the start of the rinse to 30 seconds after the end of the rinse.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhao-Shen Li, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.