Clinical trial NCT05249933: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Gastric Disease
Capsule Endoscopy
Keywords: capsule endoscopy
pronase granules
gastric preparation
visualization of gastric mucosa
randomized controlled study
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastric Cleanliness Score (GCS)
timeFrame: 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 2 weeks
measure: Fullness score
timeFrame: 2 weeks
measure: Gastric Examination Time (GET)
timeFrame: 2 weeks
measure: Esophageal transit time (ETT)
timeFrame: 2 weeks
measure: Gastric transit time (GTT)
timeFrame: 2 weeks
measure: Small bowel transit time (SBTT)
timeFrame: 2 weeks
measure: Completion Rate (CR)
timeFrame: 2 weeks
measure: Adverse events occurence rate
timeFrame: 2 weeks
measure: Detection rate of lesions
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
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.
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.
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.
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.
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.
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.