Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Cirrhosis
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| ClinicalTrials.gov Identifier: NCT03749954 |
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Recruitment Status :
Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : November 17, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Compensated Cirrhosis Gastroesophageal Varices Bleeding | Diagnostic Test: Detachable string magnetically controlled capsule endoscopy |
The presence of gastroesophageal varices (GEV) is a common and serious complication of compensated advanced chronic liver disease (cACLD).1-3 GEV hemorrhage is associated with a six week mortality rate of between 15% and 25%.2,3 In order to prevent variceal hemorrhage, screening and surveillance aims to detect high-risk varices (HRV) and determine the need for primary preventative therapy.2,3 Esophagogastroduodenoscopy (EGD) is therefore an important part of the diagnostic work-up in patients with cACLD, serving as the gold standard to diagnose HRV.2,3 However, EGD is invasive and poorly tolerated, with many patients needing intravenous sedatives or general anesthesia. Although EGD with sedation relieves patients' anxiety and discomfort and reduces the potential for physical injury during the procedure, it incurs additional risks of cardiopulmonary adverse events.4 Consequently, patients may decline a screening procedure if they are stable and asymptomatic.
Non-invasive methods for detection of cACLD are being explored.5-13 Although preliminary research is encouraging, these techniques predict the presence, rather than confirm or assess the size, of GEV. By contrast, capsule endoscopy is a non-invasive alternative which also allows direct visualization of GEV.14 A number of well-conducted trials15-19 suggest that EGD and capsule endoscopy may be equivalent in terms of accuracy in the identification and grading of varices. However, concerns remain that the quality of examination may be adversely affected by the uncontrolled and sometimes rapid transit of the capsule through the esophagus.20 String capsule endoscopy was introduced to address this concern by providing control of capsule movement as well as real-time visualization.21 However, this technique is limited by the inability to detach the string from the capsule. Thus, observation of the fundus, one of the predilection sites of varices, is impossible and retrieval of the capsule from the esophagus causes discomfort.
Magnetically controlled capsule endoscopy (MCCE), a novel modality, was developed and approved by the China Food and Drug Administration in 2013.22 Our previous studies initially demonstrated that MCCE was comparable in accuracy to EGD for gastric examination.22,23 Furthermore, it has several strengths including non-invasiveness, no sedation requirement, and easy operation.22,23 We have since combined an innovative detachable string system with the MCCE (detachable string magnetically controlled capsule endoscopy (DS-MCCE)) and carried out a pilot study showing that DS-MCCE was safe and feasible both in healthy volunteers and patients with suspected esophageal disease.24 Moreover, successful detachment of the capsule from the string avoids the discomfort of retrieving the entire capsule from the mouth and allows subsequent investigation of the gastric cardia and fundus. To our knowledge, the diagnostic accuracy of HRV, comfort and safety of DS-MCCE in patients with cACLD have not been explored in a large-scale trial. This prospective, multicenter study aimed to assess the accuracy, patient's satisfaction, and safety of DS-MCCE for detecting HRV in well-characterized patients with cACLD.
| Study Type : | Observational |
| Actual Enrollment : | 105 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Detachable String Magnetically Controlled Capsule Endoscopy for Detecting High-risk Varices in Compensated Advanced Chronic Liver Disease (CHESS1801): A Prospective Multicenter Study |
| Actual Study Start Date : | November 9, 2018 |
| Actual Primary Completion Date : | December 3, 2019 |
| Estimated Study Completion Date : | November 8, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Overall eligible participants
Eligible participants will receive standard esophagogastroduodenoscopy and magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
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Diagnostic Test: Detachable string magnetically controlled capsule endoscopy
Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
Other Name: Esophagogastroduodenoscopy |
- Diagnostic accuracy of magnetically controlled capsule endoscopy for the risk of variceal bleeding [ Time Frame: 1 day ]Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard
- Diagnostic accuracy of magnetically controlled capsule endoscopy for decompensation or death [ Time Frame: 3 year ]Diagnostic accuracy of magnetically controlled capsule endoscopy to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up
- Diagnostic accuracy of other non-invasive methods for the risk of variceal bleeding [ Time Frame: 1 day ]Diagnostic accuracy of other non-invasive methods to determine the high-risk or low-risk of variceal bleeding when compared with esophagogastroduodenoscopy as the reference standard
- Diagnostic accuracy of other non-invasive methods for decompensation or death [ Time Frame: 3 year ]Diagnostic accuracy of other non-invasive methods to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- age 18-75 years;
- confirmed cirrhosis based on liver biopsy or clinical findings;
- compensated cirrhosis;
- scheduled to undergo esophagogastroduodenoscopy;
- estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19;
- with written informed consent.
Exclusion Criteria:
- contradictions for capsule endoscopy;
- contradictions for standard magnetic resonance imaging examination such as the presence of surgical metallic devices;
- pregnancy or unknown pregnancy status.
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): NCT03749954
| China, Beijing | |
| The Fifth Medical Center of PLA General Hospital | |
| Beijing, Beijing, China | |
| China, Gansu | |
| The First Hospital of Lanzhou University | |
| Lanzhou, Gansu, China | |
| China, Guangdong | |
| Guangdong Second Provincial General Hospital | |
| Guangzhou, Guangdong, China | |
| Nanfang Hospital, Southern Medical University | |
| Guangzhou, Guangdong, China | |
| Zhujiang Hospital, Southern Medical University | |
| Guangzhou, Guangdong, China | |
| The Fifth Affiliated Hospital of Zunyi Medical University | |
| Zhuhai, Guangdong, China | |
| China, Shandong | |
| Shandong Provincial Hospital affiliated to Shandong University | |
| Jinan, Shandong, China | |
| China, Shanghai | |
| Changhai Hospital | |
| Shanghai, Shanghai, China | |
| Shanghai Tongji Hospital, Tongji University School of Medicine | |
| Shanghai, Shanghai, China | |
| China, Zhejiang | |
| Sir Run Run Shaw Hospital | |
| Hangzhou, Zhejiang, China | |
| China | |
| The Second Affiliated Hospital of Baotou Medical College | |
| Baotou, China | |
| Third Affiliated Hospital of Sun Yat-sen University | |
| Guangzhou, China | |
| United Kingdom | |
| Sheffield Teaching Hospitals NHS Trust | |
| Sheffield, United Kingdom | |
| Principal Investigator: | Xiaolong Qi, M.D. | LanZhou University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Xiaolong Qi, Professor, LanZhou University |
| ClinicalTrials.gov Identifier: | NCT03749954 |
| Other Study ID Numbers: |
CHESS1801 |
| First Posted: | November 21, 2018 Key Record Dates |
| Last Update Posted: | November 17, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Magnetically controlled capsule endoscopy Gastroesophageal varices bleeding Varices needing treatment |
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Liver Cirrhosis Varicose Veins Hemorrhage Fibrosis Pathologic Processes |
Liver Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases |