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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.
Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NERD patients | Experimental | Patients have typical reflux syndrome without esophageal injury. |
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| EE patients | Experimental | Patients have erosion(s) or ulcer(s) in esophagus. |
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| BE patients | Experimental | Patients have esophageal specialized intestinal metaplasia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upper gastrointestinal endoscopy with biopsy and collection of refluxate | Procedure | we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Reflux in GERD Patients | We analyzed the number of acid and weakly acid reflux episodes in GERD patients | Day 4 |
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Inclusion Criteria:
Clinical (patients) part
3. Clinically and/or endoscopically confirmed diagnosis of GERD
Exclusion Criteria:
Clinical: (patient)
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Ivashkin, MD,PhD,Prof. | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I.M.Sechenov First Moscow State Medical University | Moscow | 119991 | Russia | |||
| Moscow State University of Medicine and Dentistry named after A.I. Evdokimov |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21479676 | Background | Zhong YQ, Lin Y, Xu Z. Expression of IFN-gamma and IL-4 in the esophageal mucosa of patients with reflux esophagitis and Barrett's esophagus and their relationship with endoscopic and histologic grading. Dig Dis Sci. 2011 Oct;56(10):2865-70. doi: 10.1007/s10620-011-1696-9. Epub 2011 Apr 9. | |
| 21590343 | Background |
| Label | URL |
|---|---|
| I.M.Sechenov First Moscow State Medical University website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | GERD | NERD patients, EE patients and BE patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2014 |
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| Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring | Procedure | we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was <4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours. |
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| Moscow |
| 127473 |
| Russia |
| Kohata Y, Fujiwara Y, Machida H, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Tominaga K, Wei M, Wanibuchi H, Arakawa T. Role of Th-2 cytokines in the development of Barrett's esophagus in rats. J Gastroenterol. 2011 Jul;46(7):883-93. doi: 10.1007/s00535-011-0405-y. Epub 2011 May 18. |
| 15842572 | Background | Gough MD, Ackroyd R, Majeed AW, Bird NC. Prediction of malignant potential in reflux disease: are cytokine polymorphisms important? Am J Gastroenterol. 2005 May;100(5):1012-8. doi: 10.1111/j.1572-0241.2005.40904.x. |
| 11889061 | Background | Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ. Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut. 2002 Apr;50(4):451-9. doi: 10.1136/gut.50.4.451. |
| COMPLETED |
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| NOT COMPLETED |
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participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Non Erosive Reflux Disease | Participants not received drugs |
| BG001 | Erosive Esophagitis | Participants not received drugs |
| BG002 | Barrett's Esophagus | Participants not received drugs |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | years | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Expression levels macrophage CD markers from GERD patients | Mean | Standard Deviation | mg/l |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Number of Reflux in GERD Patients | We analyzed the number of acid and weakly acid reflux episodes in GERD patients | Posted | Median | Inter-Quartile Range | episodes | Day 4 |
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32 weeks
We haven't adverse events because we not used drugs in our study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NERD Patients | Patients have the typical reflux syndrome without esophageal injury. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | EE Patients | Patients have erosion(s) or ulcer(s) in esophagus. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | BE Patients | Patients have specialized esophageal intestinal metaplasia. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD, PhD Ivashkin Vladimir Trofimovich | IMSechenovMMA | +79252667987 | motility_2013@mail.ru |
| Feb 11, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
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| CD80 |
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| CD163 |
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| CD206 |
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