Pronase Granules in Gastric Cleaning

February 21, 2022 updated by: Zhuan Liao, Changhai Hospital

The Efficiency of Pronase Granules in Gastric Cleaning of Magnetically Controlled Capsule Endoscopy: a Prospective Randomized Controlled Study

Magnetically controlled capsule endoscopy (MCE) is now widely used all over the world. However, the standard gastric preparation method by dimethicone we used clinically still has mucus at the bottom of the stomach. In this study, we aimed to determine whether pronase granules is helpful to improve the cleanliness of gastric mucosa in MCE.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

As a non-invasive and well-tolerated gastrointestinal examination method, magnetically controlled capsule endoscopy (MCE) is being increasingly used in different populations in recent years. Gastric preparation is extremely important for the completion rate (CR), image quality, and diagnostic efficiency because of the plica of gastric mucosa and the autonomous movement of the capsule in the gastrointestinal tract. After a series of explorations including air-producing powder, defoamer, protease preparation, patients are asked to drink about 800 ml-1000 ml water in a short time for standard gastric filling. However, the existing problems of gastric preparation such as abdominal distension, insufficient gastric filling, and long gastric retention time deserve attention. Different from the results of Zhu et al. (DLD, 2017), the current clinical experience shows that the addition of pronase granules in gastric preparation can often reduce the mucus in the stomach. But the standardized use of pronase granules remains to be further explored.

Study Type

Interventional

Enrollment (Anticipated)

290

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese People's Liberation Army General Hospital after January 2020.
  3. Able to provide informed consent.

Exclusion Criteria:

  1. dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or post-abdominal radiation;
  2. congestive heart failure, renal insufficiency, use of anticoagulant medication,
  3. implanted metallic devices such as pacemakers, defibrillators, artificial heart valves or joint prostheses (although the low magnetic field used technically should not interfere with such devices);
  4. pregnancy;
  5. currently participating in another clinical study.
  6. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
  7. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
  8. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
  9. The patient's basic information in the database is incomplete#
  10. Patient fail to be followed up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control group
All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 200ml warm water. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.
Drug: Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8
Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.
EXPERIMENTAL: Pronase group
All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of two liters of polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at the hospital in the morning after an overnight fast (>8hours). Then they would be randomly assigned to the control group or pronase group randomly. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg dimethicone. And 25 minutes before swallowing the capsule, the patient was asked to take 20000 IU pronase Granules Combined with 1 g NaHCO3 dissolved in 200ml warm water to maintain the intragastric pH at 6 - 8. There is still have 800-1000ml water for gastric filling 10 minutes before swallowing the capsule.
Drug: Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8
Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric Cleanliness Score (GCS)
Time Frame: 2 weeks
Six primary anatomical landmarks of the stomach (cardia, fundus, body, angulus, antrum, and pylorus) were recorded for evaluation. A 4-point grading scale was introduced to define the cleanliness as excellent (no adherent mucus and foam: score 4), good (mild mucus and foam but do not obscure vision: score 3), fair (considerable amount of mucus or foam present precluding a completely reliable examination: score 2) and poor (large amount of mucus or foam residue needing water to clear it: score 1). GCS was the total scores of all six landmarks, ranging from 6 (completely unprepared) to 24 (perfect). GCS of≥18 was regarded as acceptable.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel Visualization of the small bowel
Time Frame: 2 weeks
Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.
2 weeks
Fullness score
Time Frame: 2 weeks
Fullness is the subjective feeling of patients assessed with visual analogue scale (VAS). VAS typically take the form of a straight line with two extreme states anchored at either end. In this study, it is a 100mm VAS with a question"How full do you feel?"anchored with "not at all full"at the left side and "as full as I have ever felt" at the right side. Patients will be asked to mark their feelings on the line. The distance (mm) between the far left and the marked point is the score of fullness. 0 represents no perception at all, 10 indicates pain and needs to be stopped immediately.
2 weeks
Gastric Examination Time (GET)
Time Frame: 2 weeks
The time taken for the gastric examination to the endoscopist's satisfaction.
2 weeks
Esophageal transit time (ETT)
Time Frame: 2 weeks
The time between the first image of esophagus and the first image of stomach.
2 weeks
Gastric transit time (GTT)
Time Frame: 2 weeks
The time between the first image of stomach and the last image of stomach.
2 weeks
Small bowel transit time (SBTT)
Time Frame: 2 weeks
The time between the last image of stomach and the image of ileocecal valve.
2 weeks
Completion Rate (CR)
Time Frame: 2 weeks
The completion of stomach was defined as the observation of cardia, fundus, body, angulus, antrum and pylorus and the completion of small bowel examination was defined as the ileocecal valve was photographed.The completion rate in each group was defined as the percentage of patients with a complete examination out of the total number of patients examined.
2 weeks
Adverse events occurence rate
Time Frame: 2 weeks
The safety were evaluated at two week after procedure for any adverse events such as infection, pain, nausea, vomiting and capsule impaction or retention.
2 weeks
Detection rate of lesions
Time Frame: 2 weeks
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 24, 2021

Primary Completion (ANTICIPATED)

February 20, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (ACTUAL)

February 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastric preparation of MCE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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