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The aim of this study is to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapyI(lauromacrogol injection) in management of esophageal varices.
Endoscopic procedures now play a great role in management of esophagogastric varices. Endoscopic variceal ligation(EVL) was recommended as first line therapy for primary and secondary prophylaxis in patients with esophageal varices. Previous studies have showed a superiority of EVL over endoscopic injection of sclerotherapy(EIS), mainly because of lower occurrence rate of complications. Procedure related complications were related to total amount of lauromacrogol, number of treatment and expertise of the endoscopists. Transparent cap has already been reported to assist in other endoscopic procedures, such as biopsy of Barret esophagus or endoscopic submucosal dissection. Accuracy and vision were improved with the help of transparent cap in the front of endoscopy. We have tried transparent cap-assisted sclerotherapy in some patients with in our hospital. Now a randomized controlled trial was conducted to evaluate efficacy and safety of transparent cap-assisted endoscopic sclerotherapy in management of esophageal varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cap group | Experimental | Patients will receive endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices with assistance of a transparent cap in front of gastroscopy. |
|
| Control group | Active Comparator | Patients will receive routine endoscopic sclerotherapy(lauromacrogol injection) for esophageal varices(no transparent cap involved). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assistance of a transparent cap | Procedure | Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| rebleeding rate | Rebleeding was defined as melena or hematemasis | From date of randomization until the date of first rebleeding episode, assessed up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| incidence rate of complications | Participants will be followed for up to 1 month starting from the date of enrollment.Complications associated with endoscopic treatments include transient fever, transient dysphagia, transient arrhythmias, ulceration, perforation, stricture, rebleeding, aspiration pneumonia, sepsis, peritonitis and chest pain. | From date of randomization until 1 month after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shiyao CHEN, M.D. | Zhongshan Hospital, Shanghai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 0086200032 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2017 | |
| Unrelease | Yes | |
| Release | May 1, 2017 | |
| Reset | Aug 11, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2017 | Yes | |||
| May 1, 2017 |
| ID | Term |
|---|---|
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006975 | Hypertension, Portal |
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| without a transparent cap | Procedure | Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap. |
|
| mortality rate | Patients will be followed up for 1 month and all-cause death will be recorded. | From date of randomization until the date of death, assessed up to 1 month |
| time consumption of the procedure | From the beginning of the endoscopic injection until the end of the procedure. |
| occurrence rate of bleeding during the procedure | Bleeding was defined as visible errhysis seen from gastroscopy | From the beginning of the endoscopic injection, until the end of the procedure. |
| Aug 11, 2017 |
| D008107 | Liver Diseases |