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

NCT06874673 | Not Yet Recruiting DMC

• 1 other identifier: CHEC2024-330
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

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.

Conditions

Pronase; Mucosal Clarity

Keywords

Pronase; Colonoscopy; Mucosal Clarity; Colitis; Ulcerative Colitis; Crohn's Disease; inflammatory bowel disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Colonoscopist satisfaction score

  From start to finish of the colonoscopy.

• Rinsing solution volume

  From the start of the rinse to 30 seconds after the end of the rinse.

• Ulcerative colitis endoscopic index of severity，UCEIS

  From the start of the rinse to 30 seconds after the end of the rinse.

• Endoscopic severity index of Crohn's disease, CDEIS

  From the start of the rinse to 30 seconds after the end of the rinse.

• Simplified Geboes Score, SGS

  From the start of the rinse to 30 seconds after the end of the rinse.

Study Arms (2)

Pronase Group (Group A)

EXPERIMENTAL

During colonoscopy, the mucosal surface of the intestine was rinsed with a pronase solution to remove mucus.

Drug: Pronase

Saline Group (Group B)

PLACEBO COMPARATOR

During colonoscopy, the mucosal surface of the intestine was rinsed with saline solution to remove mucus.

Drug: Saline (NaCl 0,9 %) (placebo)

Interventions

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.

Pronase Group (Group A)

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.

Saline Group (Group B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Affiliated Hospital of Jiangnan University: collaborator
• The Affiliated People's Hospital of Ningbo University: collaborator
• Shanghai 8th People's Hospital: collaborator
• Huashan Hospital: collaborator
• Shanghai Baoshan District Wusong Central Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Pudong Hospital: collaborator
• The People's Hospital of Leshan: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator
• Huadong Hospital: collaborator
• Shanghai Songjiang District Central Hospital: collaborator
• Jinshan Hospital Fudan University: collaborator
• Dongfang Hospital Affiliated to Tongji University: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (1)

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (2)

• 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 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.

  PMID: 21963063 BACKGROUND

MeSH Terms

Conditions

Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Pronase; Sodium Chloride

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Endopeptidases; Metalloproteases; Serine Proteases; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhao-Shen Li, MD, PhD

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Huan-Wei Zhang

CONTACT

86-19921942094; zhanghuanwei@smmu.edu.cn

Yu Bai, MD

CONTACT

86-021-31161335; baiyu1998@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology Dept and Digestive Endoscopy Center

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 13, 2025
• Study Start: March 17, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

CN (1)