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Gastric DiseaseNCT04479423

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

A study testing Soda-water instead of pure water to observe gastric filling in people with Gastric Disease and Capsule Endoscopy, run by Changhai Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Disease, Capsule Endoscopy
What is being tested?
Soda-water instead of pure water to observe gastric filling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
3 Dec 2020to 15 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Over 18 years and below 75 years of age
  • Plan to undergo MCCG examination in Changhai Hospital

Who cannot join

  • dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, fistulas and strictures;
  • history of gastrointestinal surgery or suspected delayed gastric emptying;
  • Implanted metallic devices such aspacemakers, defibrillators, artificial heart valves or joint prostheses;
  • Allergic to high molecular materials such as simethicone and streptozyme;
  • Pregnancy or mentally ill person;
  • currently participating in another clinical study;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

Official title: The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy: A Prospective,Single Center,Randomized Controlled Study

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.

Read more

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.

Read the detailed description

This is a prospective, single blind, randomized controlled clinical study approved by the Endoscopy Center of Changhai Hospital in Shanghai from July, 2020 to September,2020. Approval to carry out this study was granted by the Ethics Committee, Changhai Hospital, Naval Medical University.

According to the results of our pilot study, 252 participants(with 20% withdrawal rate) aged 18-75 will accept standard gastric preparation or gastric preparation with soda water randomly (ratio 1:1).All patient will provid written informed consent for this study before undergoing baseline MCE.

Investigators evaluated the feasibility of a novel gastric preparation methods regimens on gastric distention,gastric cleansing, feeling of fullness, diagnostic yield, satisfaction questionnaire, gastric transit time, small bowel transit time and completion rate. The safety were evaluated at two week after procedure for the occurance of adverse events. Investigators also plan to explore whether soda water can affect the subsequent examination of the small intestine, and the difficulty in intervention under special circumstances.

All participants 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, participants arrived at hospital in the morning after an over night fast (>8hours). Then they would be randomly assigned to controll group or soda group.

Control group:40 minutes before capsule ingestion, all participants swallowed 100ml clear water containing 50mg simethicone. During the period, participants were asked to have a proper walk to wash out bubbles. An additional 900ml clear water was drunk to obtain good vision before undergoing MCE examination.

Soda water group：Control group:40 minutes before capsule ingestion, all participants swallowed 100ml clear water containing 50mg simethicone. During the period, participants were asked to have a proper walk to wash out bubbles. An additional 400ml soda water was drunk to obtain good vision before undergoing MCE examination.

Then, the patient enter the examination room to finish the examination.

Being tested
Soda-water instead of pure water to observe gastric filling
Keywords
capsule endoscopy, gastric distention, gastric transit time, clinical trial
Medical subject headings
Stomach Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soda-water instead of pure water to observe gastric fillingProcedure or surgery

    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.

Study groups in NCT04479423
Study groupRoleWhat they receive
Soda waterExperimental400ml soda water was drunk to obtain good vision before undergoing MCE examination.
Receives: Procedure: Soda-water instead of pure water to observe gastric filling
waterNo intervention900ml clear water(100 ml water of simethicone solution was not included) was drunk to obtain good vision before undergoing MCE examination.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastric Filling of 0-5 minutes

    According to the extension of gastric plica on the great curvature, the score of gastric filling is ranged from 1 to 5 as excellent (smooth and basically no plica,score 5), good (the height of gastric plica <the distance between the adjacent gastric plica: score 4), fair (the height of gastric plica nearly same to the distance between the adjacent gastric plica: score 3),average (the height of gastric plica > the distance between the adjacent gastric plica: score 2) and poor (the folds gathered, and the gastric mucosa between plica is haedly to be seen, score 1).

    Measured: 0-5 minutes after the capsule opened

Secondary outcomes (9)

  1. 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.

    Measured: Before examination

  2. Satisfaction score of patients

    All subjects were asked about tolerance of the procedure in the following areas using a questionnaire of Preprocedure Perception and Postprocedure Satisfaction, which including ease of swallowing, pain or discomfort experienced during and after the procedure, overall tolerability of the procedure, and overall convenience of the procedure (a score of 0-4,with 0 as the worst and 4 as the best respectively, ranged from 2 to 44).

    Measured: After the procedure immediately

  3. Liquid for gastric refilling

    Count the numbers of patients who needs extra liguid which is used for better gastric distention during the examination procedure and how much they needed.

    Measured: During the procedure

  4. Gastric Examination Time (GET)

    the time taken for the gastric examination to the endoscopist's satisfaction.

    Measured: After the procedure(within 5 days)

  5. 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 defne 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.

    Measured: After the procedure(within 5 days)

  6. Transit Time

    esophageal transit time (ETT),gastric transit time (GTT) and small bowel transit time (SBTT)

    Measured: After the procedure(within 5 days)

  7. Diagnostic Yield (DY)

    diagnostic yield including polyp, ulcer, gastric fundus varices, submucosal tumor, and carditis. The difuse lesions such as superfcial, atrophic, and erosive gastritis were defned as negative fndings.

    Measured: After the procedure(within 5 days)

  8. 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.

    Measured: After the procedure(within 5 days)

  9. Gastric Filling score of 5-10 minutes

    According to the extension of gastric plica on the great curvature, the score of gastric filling is ranged from 1 to 5 as excellent (smooth and basically no plica,score 5), good (the height of gastric plica <the distance between the adjacent gastric plica: score 4), fair (the height of gastric plica nearly same to the distance between the adjacent gastric plica: score 3),average (the height of gastric plica > the distance between the adjacent gastric plica: score 2) and poor (the folds gathered, and the gastric mucosa between plica is haedly to be seen, score 1).

    Measured: 5-10 minutes after the capsule opened

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start3 Dec 2020
  3. Primary completion20 May 2021
  4. Study completion15 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479423
Sponsor's protocol ID
Soda-water in MCE
Status last verified
Jul 2023
First submitted
6 Jul 2020
Last updated
28 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang YC, Pan J, Jiang X, Su XJ, Zhou W, Zou WB, Qian YY, Chen YZ, Liu X, Yu J, Yan XN, Zhao AJ, Li ZS, Liao Z. Repetitive Position Change Improves Gastric Cleanliness for Magnetically Controlled Capsule Gastroscopy. Dig Dis Sci. 2019 May;64(5):1297-1304. doi: 10.1007/s10620-018-5415-7. Epub 2018 Dec 17.

    PubMed 30560329

  • Stubbs RJ, Hughes DA, Johnstone AM, Rowley E, Reid C, Elia M, Stratton R, Delargy H, King N, Blundell JE. The use of visual analogue scales to assess motivation to eat in human subjects: a review of their reliability and validity with an evaluation of new hand-held computerized systems for temporal tracking of appetite ratings. Br J Nutr. 2000 Oct;84(4):405-15. doi: 10.1017/s0007114500001719.

    PubMed 11103211

  • Shimpo M, Akamatsu R. The effects of bowl size and portion size on food intake and fullness ratings in a sample of Japanese men. Public Health Nutr. 2018 Dec;21(17):3216-3222. doi: 10.1017/S1368980018001842. Epub 2018 Aug 6.

    PubMed 30079861

  • Jiang X, Qian YY, Liu X, Pan J, Zou WB, Zhou W, Luo YY, Chen YZ, Li ZS, Liao Z. Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video). Gastrointest Endosc. 2018 Oct;88(4):746-754. doi: 10.1016/j.gie.2018.06.031. Epub 2018 Jul 11.

    PubMed 30005825

  • 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.

    PubMed 27211503

  • Liao Z, Duan XD, Xin L, Bo LM, Wang XH, Xiao GH, Hu LH, Zhuang SL, Li ZS. Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers. J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.

    PubMed 23687601

  • Westerhof J, Weersma RK, Koornstra JJ. Risk factors for incomplete small-bowel capsule endoscopy. Gastrointest Endosc. 2009 Jan;69(1):74-80. doi: 10.1016/j.gie.2008.04.034. Epub 2008 Aug 8.

    PubMed 18691709

  • Ohnhaus EE, Adler R. Methodological problems in the measurement of pain: a comparison between the verbal rating scale and the visual analogue scale. Pain. 1975 Dec;1(4):379-384. doi: 10.1016/0304-3959(75)90075-5.

    PubMed 800639

  • de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227.

    PubMed 18435461

  • Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

    PubMed 22036893

Questions about this trial

What is this clinical trial studying?

A study testing Soda-water instead of pure water to observe gastric filling in people with Gastric Disease and Capsule Endoscopy, run by Changhai Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric Filling of 0-5 minutes (time frame: 0-5 minutes after the capsule opened). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04479423, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.

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