NCT05249933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
290

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 9, 2022

Last Update Submit

February 21, 2022

Conditions

Gastric DiseaseCapsule Endoscopy

Keywords

capsule endoscopypronase granulesgastric preparationvisualization of gastric mucosarandomized controlled study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

    2 weeks

  • Fullness score

    2 weeks

  • Gastric Examination Time (GET)

    2 weeks

  • Esophageal transit time (ETT)

    2 weeks

  • Gastric transit time (GTT)

    2 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Pronase group

EXPERIMENTAL

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

Interventions

Deyou; Beijing Tide Pharmaceutical Co, China, containing 20,000 iu pronase granules combined with 1 g NaHCO3 to maintain the intragastric PH at 6-8DRUG

Drink Deyo with 200ml warm water 25 minutes before swallowing the capsule to remove mucus in the stomach.

Control groupPronase group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 29110963RESULT

  • 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.

    PMID: 27211503RESULT

  • 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.

    PMID: 29380729RESULT

  • 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.

    PMID: 31468267RESULT

  • 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.

    PMID: 28437000RESULT

  • 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.

    PMID: 31194028RESULT

MeSH Terms

Conditions

Stomach Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Zhuan Liao

CONTACT

021-31161024zhuanleo@126.com

Jiahui Zhu

CONTACT

18301952685jiahuizhu2685@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 22, 2022

Study Start

February 24, 2021

Primary Completion

February 20, 2022

Study Completion

March 1, 2022

Last Updated

February 22, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)