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Magnetically Controlled Capsule Endoscopy in Visualization of the UGI and Small Intestine

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ClinicalTrials.gov Identifier: NCT05069233
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital

Brief Summary:
In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

Condition or disease Intervention/treatment
Stomach Diseases Small Intestine Disease Other: UGI+SB

Detailed Description:
Magnetically controlled capsule endoscopy (MCE), with equally favorable diagnostic accuracy as conventional endoscopy, has become a painless noninvasive diagnostic modality in clinical practice. The more than 8 hours battery life of the MCE enables a further examination of the small bowel. In addition, it has been demonstrated that magnetic steering of capsule endoscopy improves the completion rate of small bowel examination by facilitating passage of the capsule through the pylorus, which further supported MCE as a practical modality for examination of both the stomach and small bowel. In this study, we retrospectively analyzed the videos of combined upper digestive tract and small intestine examination under MCE, so as to clarify the feasibility and diagnostic efficacy of MCE in one-time examination of the upper gastrointestinal and small intestinal mucosa.

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Study Type : Observational
Estimated Enrollment : 593 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Feasibility of the Magnetically Controlled Capsule Endoscopy in One Time Visualization of the Upper Gastrointestinal Tract and Small Intestine
Actual Study Start Date : September 27, 2021
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
UGI+SB
Patients who underwent combined upper digestive tract and small intestine examination under MCE.
Other: UGI+SB
Patients who underwent combined upper digestive tract and small intestine examination under MCE.




Primary Outcome Measures :
  1. Success rate of UGI and small-bowel examination [ Time Frame: 2 weeks ]
    The success rate of upper gastrointestinal tract and small-bowel examination under MCE is evaluated by the technical success rate, a composite outcome including the successful viewing of esophagus, stomach and duodenum, and complete small-bowel examination.


Secondary Outcome Measures :
  1. Visualization of the esophagus [ Time Frame: 2 weeks ]
    Visualization of the esophagus indicated by the number of images captured for Z-line and how many quadrants of the Z-line were observed. Circumferential visualization of the Z-line 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.

  2. Visualization score of the gastric mucosa [ Time Frame: 2 weeks ]
    Visualization score of the gastric mucosa To objectively evaluate the complete visualization of the gastric mucosa in the 6 anatomic landmarks (cardia, fundus, body, angulus, antrum, and pylorus), a 3-point grading scale was used: 1, poor (<70% of the mucosa was observed), 2, fair (70%-90% of the mucosa was observed), and 3, good (>90% of the mucosa was observed).

  3. Visualization of the small bowel [ Time Frame: 2 weeks ]
    Visualization of the small bowel was determined by the percentage of time during which the small-bowel view was clear, defined as not obscured more than 50% of the screen view. The clear-viewing percentage of the total small-bowel transit time assessed by a 4-point scale :0, less than 25%; 1, 25% to 49%; 2, 50% to 75%; and 3, greater than 75%.

  4. Examination time of esophagus, stomach, duodenum and small bowel [ Time Frame: 1 month ]
    Examination-related parameters included esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), pylorus transit time (PTT), small bowel transit time (SBTT). ETT is defined as the time between the first esophageal image and the first gastric image. GTT is defined as the time between the first gastric image and the first duodenal image. GET is defined as the time for examination of gastric primary anatomic landmarks twice. PTT is defined as the time between the first pyloric image and the first duodenal image. SBTT is defined as the time between the first duodenal image and the first cecal image.

  5. Detection rate of lesions [ Time Frame: 1 month ]
    The detection rate of lesions in different digestive part (esophagus, stomach, duodenum, small intestine) found by MCE.

  6. Adverse events during MCE procedure [ Time Frame: 1 month ]
    The presence of any adverse events during MCE procedure will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients who underwent upper gastrointestinal and small intestinal mucosal examination under MCE at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Those who underwent upper gastrointestinal and small intestinal mucosal examination under magnetically controlled capsule endoscopy at Shanghai Changhai Hospital and Chinese PLA General Hospital after January 2020.
  3. Able to provide informed consent.

Exclusion Criteria:

  1. Patients who fail to follow the prescribed procedures for magnetically controlled capsule endoscopy;
  2. Patients who only undergo gastric examination under magnetically controlled capsule endoscopy;
  3. Patients who only undergo small bowel examination under magnetic control capsule endoscopy;
  4. The patient's basic information in the database is incomplete;
  5. Patient fail to be followed up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069233


Contacts
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Contact: Zhuan Liao, Professor (81)02131161024 zhuanleo@126.com
Contact: Xi Jiang, PhD 81-13127952352 jiangxi_stella@126.com

Locations
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China
Changhai Hospital Recruiting
Shanghai, China, 200433
Contact: Zhuan Liao, professor    86-021-31161004    liaozhuan@smmu.edu.cn   
Sub-Investigator: Xi Jiang         
Sub-Investigator: Yawei Liu         
Sponsors and Collaborators
Changhai Hospital
Chinese PLA General Hospital
Investigators
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Principal Investigator: Zhuan Liao Changhai Hospital,Shanghai,China
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhuan Liao, Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT05069233    
Other Study ID Numbers: MCE for UGI+SB
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhuan Liao, Changhai Hospital:
capsule endoscopy
Additional relevant MeSH terms:
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Stomach Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases