Back to resultsPronase Granules in Gastric Cleaning
Primary Purpose
Gastric Disease, Capsule Endoscopy
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastric Disease focused on measuring capsule endoscopy, pronase granules, gastric preparation, visualization of gastric mucosa, randomized controlled study
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old.
- 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.
- Able to provide informed consent.
Exclusion Criteria:
- 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;
- congestive heart failure, renal insufficiency, use of anticoagulant medication,
- 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);
- pregnancy;
- currently participating in another clinical study.
- Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
- Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
- Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
- The patient's basic information in the database is incomplete#
- Patient fail to be followed up.
Sites / Locations
- Changhai HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
Pronase group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Gastric Cleanliness Score (GCS)
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.
Secondary Outcome Measures
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
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%.
Fullness score
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.
Gastric Examination Time (GET)
The time taken for the gastric examination to the endoscopist's satisfaction.
Esophageal transit time (ETT)
The time between the first image of esophagus and the first image of stomach.
Gastric transit time (GTT)
The time between the first image of stomach and the last image of stomach.
Small bowel transit time (SBTT)
The time between the last image of stomach and the image of ileocecal valve.
Completion Rate (CR)
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.
Adverse events occurence rate
The safety were evaluated at two week after procedure for any adverse events such as infection, pain, nausea, vomiting and capsule impaction or retention.
Detection rate of lesions
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05249933
Brief Title
Pronase Granules in Gastric Cleaning
Official Title
The Efficiency of Pronase Granules in Gastric Cleaning of Magnetically Controlled Capsule Endoscopy: a Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
February 20, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Disease, Capsule Endoscopy
Keywords
capsule endoscopy, pronase granules, gastric preparation, visualization of gastric mucosa, randomized controlled study
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
290 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Pronase group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
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
Intervention Description
Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.
Primary Outcome Measure Information:
Title
Gastric Cleanliness Score (GCS)
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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
Description
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%.
Time Frame
2 weeks
Title
Fullness score
Description
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.
Time Frame
2 weeks
Title
Gastric Examination Time (GET)
Description
The time taken for the gastric examination to the endoscopist's satisfaction.
Time Frame
2 weeks
Title
Esophageal transit time (ETT)
Description
The time between the first image of esophagus and the first image of stomach.
Time Frame
2 weeks
Title
Gastric transit time (GTT)
Description
The time between the first image of stomach and the last image of stomach.
Time Frame
2 weeks
Title
Small bowel transit time (SBTT)
Description
The time between the last image of stomach and the image of ileocecal valve.
Time Frame
2 weeks
Title
Completion Rate (CR)
Description
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.
Time Frame
2 weeks
Title
Adverse events occurence rate
Description
The safety were evaluated at two week after procedure for any adverse events such as infection, pain, nausea, vomiting and capsule impaction or retention.
Time Frame
2 weeks
Title
Detection rate of lesions
Description
The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old.
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.
Able to provide informed consent.
Exclusion Criteria:
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;
congestive heart failure, renal insufficiency, use of anticoagulant medication,
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);
pregnancy;
currently participating in another clinical study.
Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
The patient's basic information in the database is incomplete#
Patient fail to be followed up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuan Liao
Phone
021-31161024
Ext
81
Email
zhuanleo@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiahui Zhu
Phone
18301952685
Email
jiahuizhu2685@126.com
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Liao, professor
Phone
021-31161004
Ext
86
Email
zhuanleo@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29110963
Citation
Zhu SG, Qian YY, Tang XY, Zhu QQ, Zhou W, Du H, An W, Su XJ, Zhao AJ, Ching HL, McAlindon ME, Li ZS, Liao Z. Gastric preparation for magnetically controlled capsule endoscopy: A prospective, randomized single-blinded controlled trial. Dig Liver Dis. 2018 Jan;50(1):42-47. doi: 10.1016/j.dld.2017.09.129. Epub 2017 Oct 6.
Results Reference
result
PubMed Identifier
27211503
Citation
Liao Z, Hou X, Lin-Hu EQ, Sheng JQ, Ge ZZ, Jiang B, Hou XH, Liu JY, Li Z, Huang QY, Zhao XJ, Li N, Gao YJ, Zhang Y, Zhou JQ, Wang XY, Liu J, Xie XP, Yang CM, Liu HL, Sun XT, Zou WB, Li ZS. Accuracy of Magnetically Controlled Capsule Endoscopy, Compared With Conventional Gastroscopy, in Detection of Gastric Diseases. Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
Results Reference
result
PubMed Identifier
29380729
Citation
Krijbolder MS, Grooteman KV, Bogers SK, de Jong DJ. Addition of simethicone improves small bowel capsule endoscopy visualisation quality. Neth J Med. 2018 Jan;76(1):27-31.
Results Reference
result
PubMed Identifier
31468267
Citation
Cave DR, Hakimian S, Patel K. Current Controversies Concerning Capsule Endoscopy. Dig Dis Sci. 2019 Nov;64(11):3040-3047. doi: 10.1007/s10620-019-05791-4.
Results Reference
result
PubMed Identifier
28437000
Citation
Shamsudhin N, Zverev VI, Keller H, Pane S, Egolf PW, Nelson BJ, Tishin AM. Magnetically guided capsule endoscopy. Med Phys. 2017 Aug;44(8):e91-e111. doi: 10.1002/mp.12299. Epub 2017 Jun 23.
Results Reference
result
PubMed Identifier
31194028
Citation
Jiang X, Pan J, Li ZS, Liao Z. Standardized examination procedure of magnetically controlled capsule endoscopy. VideoGIE. 2019 May 30;4(6):239-243. doi: 10.1016/j.vgie.2019.03.003. eCollection 2019 Jun. No abstract available.
Results Reference
result
Learn more about this trial
Pronase Granules in Gastric Cleaning
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