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The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy

NCT04479423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-07-28

No results posted yet for this study

Summary

Magnetically controlled capsule endoscopy (MCE) is a noninvasive technique (90.4% sensitivity, 94.7% specificity and 93.4% accuracy) without requiring sedation or air insufflation, which makes it welcomed by most of participants. However, due to the large size of the stomach, clear views are obtained with the stomach distended. Participants were asked to drink 1000ml water for gastric preparation in a short time according to the standard procesure. It is hard for some participants especially the old and can cause discomfort. If the capsule stays in the stomach for a long time (\>4 hours), it will affect the completion rate of small intestine examination and be inconvient to both of the endoscopist and patient.

It is a promising way to fill the stomach with carbonated drinks in some diagnosis and treatment methods. A study using carbonated drinks for gastric filling in the procedure of multi slice spiral computed tomography (MSCT) showed higher diagnostic rate for gastric cancer (85%VS80%). Rapid filling and absorption, greater comfort feeling and little pressure changes lead to higher acceptance of participants.

So, researchers have a novel idea using soda water to take place of pure water in the gastric preparation. The combination of gas and liquid in gastric filling greatly reduces the amount of fluid that participants need to drink, which makes the shorter preparation time and less feeling of fullness. In a pilot study before, investigators found the usage of soda water obtained similar gastric distention score and shorter gastric transit time (GTT) than standard preparation method.

This prospective, single blind, randomized controlleds trial aimed to prove the safety and efficiency of soda water in the process of gastric preparation and explore the impact on the follow-up small bowel examination.

Conditions

  • Gastric Disease
  • Capsule Endoscopy

Interventions

PROCEDURE

Soda-water instead of pure water to observe gastric filling

All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of 2L polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at hospital in the morning after an over night fast (\>8hours). Then they would be randomly assigned to controll group or soda group. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg simethicone. During the period, patients were asked to have a proper walk to wash out bubbles. An additional 900ml pure water or 400ml soda-water was drunk to obtain good vision before undergoing MCE examination.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Liao Zhuan, MD · Department of Gastroenterology, Changhai Hospital, the Naval Medical University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2021-05-20
Completion
2021-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479423 on ClinicalTrials.gov