Capsule Endoscopy
Conditions
Keywords
SG-MCCG, Z-line visualization, Image quality, Gastric examination time, Manipulation performance
Brief summary
The aim of this study is to evaluate the clinical application of the second-generation MCCG with higher image resolution and frame rate for upper gastrointestinal tract compared with the first-generation.
Detailed description
Magnetically controlled capsule gastroscopy (MCCG) has been widely used in clinical practice for gastric examination. However, there still exist blind spots under MCCG, particularly in the esophagus and duodenum. Although the anatomy of the esophagus and duodenum can be the main cause, MCCG still needs technical improvement. In addition, the gastric examination time under MCCG can be further optimized. Therefore, a new-generation MCCG is developed with a higher frame rate improved from 0.5-2 to 0.5-8 frames per second, image resolution improved from 480 x 480 to 720 x 720, view angle improved from 140° to 150°, wireless anti-jamming technology is applied as a more effective and stable information transmission method. This is a prospective, single-centered, blinded randomized controlled pilot study. Subjects receiving MCCG at Changhai Hospital will be randomly allocated into two groups with a ratio of 1:1 before the procedure, the first-generation or the second-generation MCCG. After passage through the esophagus, the gastric examination and transpyloric passage of the capsule is conducted under magnetic steering, and then examination is continued in the small bowel under intestinal peristalsis.
Interventions
DEVICEthe second-generation MCCG
Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * Refused abdominal surgery to take out the capsule in case of capsule retention * Implanted pacemaker, except the pacemaker is compatible with MRI * Other implanted electromedical devices or magnetic metal foreign bodies * Pregnancy or suspected pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circumferential Visualization of the Z-line | Through end of examination, up to 30 minutes | Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection Rate of Duodenal Papilla | up to 2 days after the examination | Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained |
| Gastric Examination Time (GET) | Through end of examination, up to 30 minutes | Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus). |
| Manipulation Performance Score of the MCCG | up to 10 minutes after the examination | The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best. |
| Image Quality Score (Mainly Focus on Clarity) | up to 30 minutes after the examination | Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD). |
| The Incidence of Adverse Events (The Safety of MCCG) | up to 2 weeks after the examination | The presence of adverse events within two weeks aftter swallowing MCCG will be recorded. |
| Number of Participants With Lesions in Upper Gastrointestinal Tract | up to 2 days after the examination | calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG. |
| Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | up to 2 days after the examination | Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends. |
| Cleansing Level Score of Z-line Area | Through end of examination, up to 30 minutes | The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area. |
| Transit Time of MCCG in Esophagus | up to 2 days after the examination | Assess the transit time of MCCG in esophagus from starts take images to ends. |
| The Number of Images Captured for Esophagus and Z-line | up to 30 minutes after the examination | The number of images captured by MCCG for esophagus and Z-line. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| The First-generation MCCG Group The patients swallowed the first-generation MCCG with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination twice, the endoscopist controlled the capsule to face the pylorus and drag it close to the pylorus. The capsule would enter the duodenal bulb and was held stationary to investigate the duodenal bulb using the 360-degree automatic scanning mode. In the descending part of duodenum, the endoscopist tried to control the capsule to view the major papilla. After passing through the duodenum, the capsule started to complete the small-bowel examination with the small-bowel mode. The magnetic steering time for passing through the pylorus was not allowed more than 15 min. | 40 |
| The Second-generation MCCG Group All process in this study were the same except that the second-generation capsule (Ankon Navicam-2) was used in the experimental group.
the second-generation MCCG: Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2). | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | The First-generation MCCG Group | Total | The Second-generation MCCG Group |
|---|---|---|---|
| Age, Continuous | 48.45 years STANDARD_DEVIATION 13.51 | 48.51 years STANDARD_DEVIATION 13.79 | 48.58 years STANDARD_DEVIATION 14.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 80 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Helicobacter pylori (Hp) infection | 7 Participants | 14 Participants | 7 Participants |
| History of abdominal surgery, smoking and drinking Drinking history | 4 Participants | 6 Participants | 2 Participants |
| History of abdominal surgery, smoking and drinking History of abdominal surgery | 4 Participants | 7 Participants | 3 Participants |
| History of abdominal surgery, smoking and drinking Smoking history | 7 Participants | 12 Participants | 5 Participants |
| Indication Abdominal pain or distension | 20 Participants | 39 Participants | 19 Participants |
| Indication Acid reflux or nausea/vomit | 5 Participants | 10 Participants | 5 Participants |
| Indication Chronic diarrhea | 6 Participants | 10 Participants | 4 Participants |
| Indication Physical examination | 9 Participants | 21 Participants | 12 Participants |
| Region of Enrollment China | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Female | 16 Participants | 33 Participants | 17 Participants |
| Sex: Female, Male Male | 24 Participants | 47 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Circumferential Visualization of the Z-line
Circumferential visualization of the Z-line is defined by quadrants as follows: less than 2 quadrants (\< 50%) of the Z line observed; at least 2 quadrants (50%-75%) observed; at least 3 quadrants (\>75%) observed; and entire Z line (100%) observed.
Time frame: Through end of examination, up to 30 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The First-generation MCCG Group | Circumferential Visualization of the Z-line | 100% of Z-line | 0 Participants |
| The First-generation MCCG Group | Circumferential Visualization of the Z-line | ≥50% of Z-line | 5 Participants |
| The First-generation MCCG Group | Circumferential Visualization of the Z-line | <50% of Z-line | 12 Participants |
| The First-generation MCCG Group | Circumferential Visualization of the Z-line | 0% of Z-line | 23 Participants |
| The Second-generation MCCG Group | Circumferential Visualization of the Z-line | 0% of Z-line | 16 Participants |
| The Second-generation MCCG Group | Circumferential Visualization of the Z-line | 100% of Z-line | 5 Participants |
| The Second-generation MCCG Group | Circumferential Visualization of the Z-line | <50% of Z-line | 12 Participants |
| The Second-generation MCCG Group | Circumferential Visualization of the Z-line | ≥50% of Z-line | 7 Participants |
Secondary
Cleansing Level Score of Z-line Area
The bubbles/saliva on the Z line area will be scored as follows: 0 = no bubbles/saliva on the Z line area;1 = a few bubbles/saliva on the Z line area; 2= increased amount of bubbles/saliva on the Z line area; 3 = severe bubbles/saliva on the Z line area.
Time frame: Through end of examination, up to 30 minutes
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The First-generation MCCG Group | Cleansing Level Score of Z-line Area | No bubbles | 13 Participants |
| The First-generation MCCG Group | Cleansing Level Score of Z-line Area | A few bubbles | 18 Participants |
| The First-generation MCCG Group | Cleansing Level Score of Z-line Area | Increased amount of bubbles | 7 Participants |
| The First-generation MCCG Group | Cleansing Level Score of Z-line Area | Severe bubbles | 2 Participants |
| The Second-generation MCCG Group | Cleansing Level Score of Z-line Area | Severe bubbles | 2 Participants |
| The Second-generation MCCG Group | Cleansing Level Score of Z-line Area | No bubbles | 11 Participants |
| The Second-generation MCCG Group | Cleansing Level Score of Z-line Area | Increased amount of bubbles | 5 Participants |
| The Second-generation MCCG Group | Cleansing Level Score of Z-line Area | A few bubbles | 22 Participants |
Secondary
Detection Rate of Duodenal Papilla
Detection rate of duodenal papilla means the percentage of patients with at least one image of duodenal papilla was obtained
Time frame: up to 2 days after the examination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The First-generation MCCG Group | Detection Rate of Duodenal Papilla | 3 Participants |
| The Second-generation MCCG Group | Detection Rate of Duodenal Papilla | 6 Participants |
Secondary
Gastric Examination Time (GET)
Record the time taken for endoscopist to finish the gastric examination for primary anatomical landmarks twice (cardia, fundus, body, angulus, antrum and pylorus).
Time frame: Through end of examination, up to 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The First-generation MCCG Group | Gastric Examination Time (GET) | 7.78 minutes | Standard Deviation 0.97 |
| The Second-generation MCCG Group | Gastric Examination Time (GET) | 5.24 minutes | Standard Deviation 0.74 |
Secondary
Image Quality Score (Mainly Focus on Clarity)
Assess Image quality grade ranged from 1 to 10 (1, the worst quality; 10, the quality of the best image captured by EGD).
Time frame: up to 30 minutes after the examination
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The First-generation MCCG Group | Image Quality Score (Mainly Focus on Clarity) | 7.90 score on a scale | Standard Deviation 0.61 |
| The Second-generation MCCG Group | Image Quality Score (Mainly Focus on Clarity) | 8.63 score on a scale | Standard Deviation 0.57 |
Secondary
Manipulation Performance Score of the MCCG
The performance of maneuverability is assessed using a semi-quantitative score related to the fluency, stability and comfortableness for examination procedure. Fluency is mainly reflected on the response speed to operation and smoothness of video playing. Stability is about the ability of holding the position for a long enough time and the real-time viewing of all images. comfortableness is the operator's sensation about manipulative force and fatigue degree. Maneuverability score was defined as a total scale of 3 to 15 calculated by adding up each evaluation index score above, and each index was graded from 1 to 5, with 1 as the worst and 5 as the best.
Time frame: up to 10 minutes after the examination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The First-generation MCCG Group | Manipulation Performance Score of the MCCG | Fluency | 3.04 score on a scale | Standard Deviation 0.51 |
| The First-generation MCCG Group | Manipulation Performance Score of the MCCG | Comfortableness | 3.16 score on a scale | Standard Deviation 0.45 |
| The First-generation MCCG Group | Manipulation Performance Score of the MCCG | Stability | 3.84 score on a scale | Standard Deviation 0.55 |
| The First-generation MCCG Group | Manipulation Performance Score of the MCCG | Total score | 10.05 score on a scale | Standard Deviation 1.04 |
| The Second-generation MCCG Group | Manipulation Performance Score of the MCCG | Total score | 13.28 score on a scale | Standard Deviation 0.9 |
| The Second-generation MCCG Group | Manipulation Performance Score of the MCCG | Fluency | 4.59 score on a scale | Standard Deviation 0.42 |
| The Second-generation MCCG Group | Manipulation Performance Score of the MCCG | Stability | 4.17 score on a scale | Standard Deviation 0.5 |
| The Second-generation MCCG Group | Manipulation Performance Score of the MCCG | Comfortableness | 4.51 score on a scale | Standard Deviation 0.43 |
Secondary
Number of Participants With Lesions in Upper Gastrointestinal Tract
calculate the number of participants with lesions in different part of upper gastrointestinal tract (esophagus, stomach, duodenum, jejunoileum), and preliminarily evaluate the diagnostic efficacy of the new-generation MCCG.
Time frame: up to 2 days after the examination
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| The First-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | Inflammation | 25 Participants |
| The First-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | Focal lesions | 12 Participants |
| The First-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | normal | 3 Participants |
| The Second-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | Inflammation | 24 Participants |
| The Second-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | Focal lesions | 13 Participants |
| The Second-generation MCCG Group | Number of Participants With Lesions in Upper Gastrointestinal Tract | normal | 3 Participants |
Secondary
The Incidence of Adverse Events (The Safety of MCCG)
The presence of adverse events within two weeks aftter swallowing MCCG will be recorded.
Time frame: up to 2 weeks after the examination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The First-generation MCCG Group | The Incidence of Adverse Events (The Safety of MCCG) | 0 Participants |
| The Second-generation MCCG Group | The Incidence of Adverse Events (The Safety of MCCG) | 0 Participants |
Secondary
The Number of Images Captured for Esophagus and Z-line
The number of images captured by MCCG for esophagus and Z-line.
Time frame: up to 30 minutes after the examination
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| The First-generation MCCG Group | The Number of Images Captured for Esophagus and Z-line | The number of images captured for esophagus | 97 images |
| The First-generation MCCG Group | The Number of Images Captured for Esophagus and Z-line | The number of images captured for Z-line | 0 images |
| The Second-generation MCCG Group | The Number of Images Captured for Esophagus and Z-line | The number of images captured for esophagus | 171 images |
| The Second-generation MCCG Group | The Number of Images Captured for Esophagus and Z-line | The number of images captured for Z-line | 2 images |
Secondary
Transit Time of MCCG in Esophagus
Assess the transit time of MCCG in esophagus from starts take images to ends.
Time frame: up to 2 days after the examination
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The First-generation MCCG Group | Transit Time of MCCG in Esophagus | 59.5 seconds |
| The Second-generation MCCG Group | Transit Time of MCCG in Esophagus | 44.5 seconds |
Secondary
Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time
Assess the transit time of MCCG in the gastrointestinal tract (stomach and small bowel), and record the total running time from starts take images to ends.
Time frame: up to 2 days after the examination
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| The First-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Gastric transit time (min) | 53.09 minutes |
| The First-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Small-bowel transit time (min) | 327.60 minutes |
| The First-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Total running time (min) | 702.83 minutes |
| The Second-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Gastric transit time (min) | 48.35 minutes |
| The Second-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Small-bowel transit time (min) | 297.22 minutes |
| The Second-generation MCCG Group | Transit Time of MCCG in the Gastrointestinal Tract and Total Running Time | Total running time (min) | 1001.99 minutes |