Capsule Endoscopy Clinical Trial
Official title:
The Usage of Soda-Water in Gastric Preparation for Magnetically Controlled Capsule Endoscopy: A Prospective,Single Center,Randomized Controlled Study
Verified date | July 2023 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 252 |
Est. completion date | June 15, 2021 |
Est. primary completion date | May 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Over 18 years and below 75 years of age - Plan to undergo MCCG examination in Changhai Hospital Exclusion Criteria: - 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; |
Country | Name | City | State |
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China | Changhai Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
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Changhai Hospital |
China,
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Type | Measure | Description | Time frame | Safety issue |
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Other | 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. | After 2-week follow-up period. | |
Primary | 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 0-5 minutes after the capsule opened |
| |
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. | Before examination | |
Secondary | 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). | After the procedure immediately | |
Secondary | 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. | During the procedure | |
Secondary | Gastric Examination Time (GET) | the time taken for the gastric examination to the endoscopist's satisfaction. | After the procedure(within 5 days) | |
Secondary | 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. | After the procedure(within 5 days) | |
Secondary | Transit Time | esophageal transit time (ETT),gastric transit time (GTT) and small bowel transit time (SBTT) | After the procedure(within 5 days) | |
Secondary | 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. | After the procedure(within 5 days) | |
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. | After the procedure(within 5 days) | |
Secondary | 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 5-10 minutes after the capsule opened |
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