Detachable String MCE for Upper Gastrointestinal Tract and Small Bowel
- Conditions
- Capsule Endoscopy
- Interventions
- Device: DS-MCE
- Registration Number
- NCT04329468
- Lead Sponsor
- Zhuan Liao
- Brief Summary
This study aims to evaluate the feasibility and safety of DS-MCE with a novel way for complete examination in UGI tract and small bowel, compared with EGD.
- Detailed Description
Magnetically controlled capsule endoscopy (MCE) has been widely used in clinical practice for upper gastrointestinal (UGI) tract and Small Bowel. However, the complete visualization of UGI tract still present challenges due to rapid transit through esophagus and duodenum, although technical improvements of MCE are helpful.
Detachable String MCE (DS-MCE) can control the movement of MCE through the string and MCE can start next examination after string detachment, which was proved to be an effective and safe method for complete viewing of the esophagus and stomach. In order to improve the duodenum visualization, endoscopist separate MCE from the string after finishing UGI examination so that can inspect the esophagus, stomach and duodenum under the string and magnetic field control.
This is a prospective, single-centered, self-controlled pilot study. Subjects with or without digestive symptoms receiving UGI endoscopy will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 25
- Adult patients aged 18 to 80
- With or without gastrointestinal complaints
- Scheduled to undergo a capsule endoscopy for both stomach and small bowel
- Signed the informed consents before joining this study
- Pacemakers or electromedical devices implanted which are incompatible with magnetic field;
- Suspected or known gastrointestinal stenosis, obstruction or other known risk factors for capsule retention;
- Scheduled magnetic resonance imaging examination before excretion of capsule;
- Pregnancy or suspected pregnancy;
- Any contraindications about EGD.
- Other circumstances that doctors consider inappropriate for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DS-MCE examination DS-MCE Subjects with or without digestive symptoms will be enrolled to take DS-MCE and conventional esophagogastroduodenoscopy (EGD) within 48h successively.
- Primary Outcome Measures
Name Time Method Success rate of UGI and small-bowel examination up to 2 weeks The feasibility of DS-MCE examination with a novel way is evaluated by the technical success rate, a composite outcome including the successful separation of the string and MCE, repeat viewing of esophagus, stomach and duodenum, and complete small-bowel examination.
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy up to 2 weeks The diagnostic accordance rate, sensitivity and specificity of lesions detected by DS-MCE compared with EGD.
Safety of DS-MCE procedure: presence of any adverse events during DS-MCE procedure will be recorded up to 2 weeks The presence of any adverse events during DS-MCE procedure will be recorded.
Detection rate of Z-line, duodenal papilla and pyloric retrograde view up to 2 weeks The detection means that at least one image of anatomical structure was obtained.
Circumferential visualization of the Z-line and duodenal papilla up to 2 weeks It is defined by quadrants as follows: less than 2 quadrants (\< 50%) observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire structure (100%) observed.
Cleansing level of Z-line and duodenal papilla area up to 2 weeks The effect of bubbles/saliva on the appearance of the Z line or duodenal papilla area was both scored as follows: 0=no interference by bubbles/saliva;1=minor interference of bubbles/saliva; 2=major interference of bubbles/saliva.
Visualization level of stomach up to 2 weeks Visualization level of gastric primary anatomic landmarks: cardia, fundus, body, angulus, antrum and pylorus. (good, \>75% of mucosa was observed; moderate, 50% to 75% was observed; poor, \<50% of the gastric mucosa was observed)
Examination time of esophagus, stomach, duodenum and small bowel up to 2 weeks Record the time taken to finish examination in different digestive part.
Pyloric transit time up to 2 weeks Record the time from completion of the gastric examination to the capsule entering the duodenum.
Discomfort scores associated with DS-MCE up to 2 weeks Discomfort caused by the string, swallowing the DS-MCE, pulling the capsule up or down, and pulling the string out were on a scale from 0 to 3 (0=none;1=mild/minimal; 2=moderate; and 3=severe/very difficult) according to the Ramirez system. Overall discomfort was scored on a scale of 0 to 10 (0=no discomfort; 10=the overall discomfort of EGD) according to our previous system.
Image quality scores up to 2 weeks Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
Detection rate of lesions up to 2 weeks The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, jejunoileum) found by MCE.
Trial Locations
- Locations (1)
Changhai Hospital
🇨🇳Shanghai, China