Pronase Granules in Gastric Cleaning

Capsule Endoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05249933
• Other study ID #: Gastric preparation of MCE
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 24, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2021
• Source: Changhai Hospital
• Contact: Zhuan Liao
• Phone: 021-31161024
• Email: zhuanleo[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: March 1, 2022
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Capsule Endoscopy
• Gastric Disease
• Stomach Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. Review. — View 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. — View 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. — View 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 Wi — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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%.	2 weeks
Secondary	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.	2 weeks
Secondary	Gastric Examination Time (GET)	The time taken for the gastric examination to the endoscopist's satisfaction.	2 weeks
Secondary	Esophageal transit time (ETT)	The time between the first image of esophagus and the first image of stomach.	2 weeks
Secondary	Gastric transit time (GTT)	The time between the first image of stomach and the last image of stomach.	2 weeks
Secondary	Small bowel transit time (SBTT)	The time between the last image of stomach and the image of ileocecal valve.	2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	Detection rate of lesions	The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.	2 weeks