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

NANot yet recruitingINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

March 17, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

November 30, 2025

Conditions
PronaseMucosal Clarity
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, 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.

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.

Trial Locations (1)

200433

Changhai Hospital, Naval Medical University, Shanghai

All Listed Sponsors
collaborator

Affiliated Hospital of Jiangnan University

OTHER

collaborator

The Affiliated People's Hospital of Ningbo University

OTHER_GOV

collaborator

Shanghai 8th People's Hospital

OTHER

collaborator

Huashan Hospital

OTHER

collaborator

Shanghai Baoshan District Wusong Central Hospital

UNKNOWN

collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Shanghai Pudong Hospital

OTHER

collaborator

The People's Hospital of Leshan

OTHER

collaborator

Shanghai Pudong New Area Gongli Hospital

OTHER

collaborator

Huadong Hospital

OTHER

collaborator

Shanghai Songjiang District Central Hospital

UNKNOWN

collaborator

Jinshan Hospital Fudan University

OTHER

collaborator

Dongfang Hospital Affiliated to Tongji University

OTHER

collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

lead

Changhai Hospital

OTHER

NCT06874673 - Pronase in Improving Endoscopic Mucosal Clarity During Colonoscopy for Patients with Colitis | Biotech Hunter | Biotech Hunter