Liver Cirrhosis Clinical Trial
Official title:
Accuracy of Magnetically Maneuvered Capsule Endoscopy for Detection of Esophagogastric Varices in Patients With Cirrhosis
NCT number | NCT03748563 |
Other study ID # | CENTERS |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 7, 2021 |
Est. completion date | March 6, 2023 |
Verified date | July 2023 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a diagnostic accuracy study. Eligible individuals will be enrolled and asked to undergo ds-MCE and EGD examinations. EGD is the reference standard against which ds-MCE is compared, and it will be performed within 48 hours after ds-MCE examination. The primary outcome is the sensitivity and specificity of ds-MCE in identifying the presence of esophagogastric (EGV) in patients with cirrhosis, using detection by EGD as the reference. The diagnostic accuracy of ds-MCE in detection of high-risk EV, high-risk EGV, EV, large EV, red signs of EV, GV, cardiofundal GV and PHG compared with the EGD will also be assessed. The incidence of PHE in small bowel under ds-MCE, the examination time of ds-MCE and EGD procedures, patient satisfaction assessment and safety evaluation will also be evaluated.
Status | Completed |
Enrollment | 607 |
Est. completion date | March 6, 2023 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Gender is not limited. 2. Patients aged 18 years or older. 3. Both inpatients and outpatients. 4. Clinically evident or biopsy-proven liver cirrhosis. 5. Able to provide informed consent. Exclusion Criteria: 1. Patients aged less than 18 years. 2. Patients with Zenker's diverticulum. 3. Patients with active gastrointestinal bleeding. 4. Patients who have participated in or are participating in other clinical trials. 5. Pregnancy or suspected pregnancy. 6. Suspected or known intestinal stenosis or other known risk factors for capsule retention. 7. Pacemaker or other implanted electromedical devices which could interfere with magnetic resonance. 8. Patients with dysphagia. 9. Life-threatening conditions. 10. Patients plan to undergo magnetic resonance imaging examination before excretion of the MCE. 11. Patients who refuse to give informed consent. 12. Patients with any condition that precludes compliance with the study. |
Country | Name | City | State |
---|---|---|---|
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | Zhujiang Hospital,Southern Medical University | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Zhejiang Chinese Medical University | Hanzhou | Zhejiang |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Changhai Hospital | Shanghai | |
China | Ruijin Hospital | Shanghai | Shanghai |
China | Shanghai East Hospital, Tongji University School of Medicine | Shanghai | Shanghai |
China | Shanghai Jiao Tong University affiliated Sixth people's Hospital | Shanghai | Shanghai |
China | Shanghai Pudong New Area Gongli Hospital | Shanghai | Shanghai |
China | Shanghai Tongji Hospital, Tongji University School of Medicine | Shanghai | Shanghai |
China | Yangpu District Central Hospital Affiliated to Tongji University | Shanghai | Shanghai |
China | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
China | First Affiliated Hospital Xi'an Jiaotong University | Xi'an | Shanxi |
China | the Fifth Affiliated Hospital of Zunyi Medical University | Zhuhai | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital | First Affiliated Hospital Xi'an Jiaotong University, Qilu Hospital of Shandong University, Ruijin Hospital, Shanghai East Hospital of Tongji University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Pudong New Area Gongli Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, The Fifth Affiliated Hospital of Zunyi Medical College, The First Affiliated Hospital of Zhejiang Chinese Medical University, The Third Xiangya Hospital of Central South University, Wuhan Union Hospital, China, Yangpu District Central Hospital Affiliated to Tongji University, Zhujiang Hospital |
China,
D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385. — View Citation
de Franchis R, Eisen GM, Laine L, Fernandez-Urien I, Herrerias JM, Brown RD, Fisher L, Vargas HE, Vargo J, Thompson J, Eliakim R. Esophageal capsule endoscopy for screening and surveillance of esophageal varices in patients with portal hypertension. Hepatology. 2008 May;47(5):1595-603. doi: 10.1002/hep.22227. — View Citation
de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. — View Citation
Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052. — View Citation
Gralnek IM, Adler SN, Yassin K, Koslowsky B, Metzger Y, Eliakim R. Detecting esophageal disease with second-generation capsule endoscopy: initial evaluation of the PillCam ESO 2. Endoscopy. 2008 Apr;40(4):275-9. doi: 10.1055/s-2007-995645. — View Citation
Kodama M, Uto H, Numata M, Hori T, Murayama T, Sasaki F, Tsubouchi N, Ido A, Shimoda K, Tsubouchi H. Endoscopic characterization of the small bowel in patients with portal hypertension evaluated by double balloon endoscopy. J Gastroenterol. 2008;43(8):589-96. doi: 10.1007/s00535-008-2198-1. Epub 2008 Aug 17. — View Citation
Lapalus MG, Dumortier J, Fumex F, Roman S, Lot M, Prost B, Mion F, Ponchon T. Esophageal capsule endoscopy versus esophagogastroduodenoscopy for evaluating portal hypertension: a prospective comparative study of performance and tolerance. Endoscopy. 2006 Jan;38(1):36-41. doi: 10.1055/s-2006-924975. — View Citation
North Italian Endoscopic Club for the Study and Treatment of Esophageal Varices. Prediction of the first variceal hemorrhage in patients with cirrhosis of the liver and esophageal varices. A prospective multicenter study. N Engl J Med. 1988 Oct 13;319(15):983-9. doi: 10.1056/NEJM198810133191505. — View Citation
Sarin SK, Lahoti D, Saxena SP, Murthy NS, Makwana UK. Prevalence, classification and natural history of gastric varices: a long-term follow-up study in 568 portal hypertension patients. Hepatology. 1992 Dec;16(6):1343-9. doi: 10.1002/hep.1840160607. — View Citation
Spina GP, Arcidiacono R, Bosch J, Pagliaro L, Burroughs AK, Santambrogio R, Rossi A. Gastric endoscopic features in portal hypertension: final report of a consensus conference, Milan, Italy, September 19, 1992. J Hepatol. 1994 Sep;21(3):461-7. doi: 10.1016/s0168-8278(05)80329-0. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the diagnostic accuracy of the ds-MCE in identifying the presence of esophagogastric varices (EGV) | the sensitivity and specificity of ds-MCE in identifying EGV in patients with cirrhosis, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in identifying the presence of esophageal varices (EV) | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of EV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in identifying the red sign of EV | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in identifying the red sign of EV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in differentiating large esophageal varices | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of large EV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the optimal esophageal luminal circumference percentage threshold under ds-MCE for distinguishing large EV | To investigate the optimal threshold of the proportion of ds-MCE esophageal luminal circumference occupied by the largest esophageal varix present in differentiating large EV from small or no EV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in differentiating high-risk esophageal varices | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in detection of high-risk EGV | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of high-risk EGV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in detecting gastric varices (GV) | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of GV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in detecting cardiofundal gastric varices | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of cardiofundal GV, using the detection by EGD as the reference. | 2 weeks | |
Secondary | the diagnostic accuracy of the ds-MCE in identifying portal hypertensive gastropathy | The sensitivity, specificity, PPV, NPV and overall diagnostic accuracy of ds-MCE in detection of portal hypertensive gastropathy (PHG), using the detection by EGD as the reference. | 2 weeks | |
Secondary | the incidence of portal hypertensive enteropathy (PHE) under ds-MCE | Endoscopic findings of PHE include mucosal inflammatory-like abnormalities, vascular lesions and spontaneous bleeding. | 2 weeks | |
Secondary | the examination time of ds-MCE and EGD | Examination time of ds-MCE include esophageal transit time (ETT), gastric examination time (GET), gastric transit time (GTT), small bowel transit time (SBTT), and total running time (TRT). Examination time of EGD is the time from the endoscope entering to exiting from the esophagus. | 2 weeks | |
Secondary | patient satisfaction evaluation of the ds-MCE and EGD | Patient satisfaction score of ds-MCE and EGD procedures. | 2 weeks | |
Secondary | Safety evaluation | All adverse events occurring during the study will be recorded. | 2 weeks |
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