Endoscopic Transpapillary Interventions.
关键词
抽象
描述
Sph of Oddi consists of a circular inner muscle layer and a longitudinal outer muscle layer. The circular layer does not depend on the duodenum. The longitudinal layer passes from the wall of the duodenum and separates ascending and descending parts superimposing over its circular layer. The arrangement of these layers towards each others is constant. Mostly ERCP complications are caused by the interventions in major papilla and remain at a high level of frequency up to 23 % Cutting all the layers of duodenum leads to bleeding up to 3 %. The perforation might happened up to 1 % Destruction of the opening mechanism after sphincterotomy leads to develop of reflux cholangitis, acute cholecystitis. It is possible to avoid further cholecystectomy only in 10% of patients. Incapability of performing the retrograde sphincterotomy in patients with extended papillary stenosis led to the creation of a new method - ASD. Retrograde and antegrade sphincterotomies are analysed. 750 patients underwent ASD within 7 years 65 % in urgent cases . Relative risk of complication after ASD performing 3 times less. Taking into consideration possible post-ASD inner edema, plastic biliary/pancreatic stent(s) are required during 5-10 days after. Standard methods for post ERCP pancreatitis prevention must be applied in all cases. The new method performed some selective. First of all young patient with alone stone in the common bile duct, women after after childbirth. secondly, elderly patient were cured by ASD. And as well as a group of patients with severe comorbid diseases, such as renal failure, acute myocardial infarction. In our research, in two patients with AIDS was performed ASD. They were on special treatment after being diagnosed with HIV-infection, within 2 years. It was SSC. Papillary stenosis and cholangiolithiasis were cured successfully. The use of ASD with preservation of the closure function of the sph. Oddi allowed to avoid cholecystectomy in 71.2%. ASD can be performed new design of sphincterotome. It takes into account the anatomical structure of sph. Oddi and is recommended as an alternative to standard sphincterotomy, balloon dilatation and drainage interventions (RR 0,55 [95%CI 0,18 to 1,67]. ASD must be performed by an endoscopist with experience in transpapillary intervention.
日期
最后验证: | 04/30/2020 |
首次提交: | 05/01/2020 |
提交的预估入学人数: | 05/23/2020 |
首次发布: | 05/28/2020 |
上次提交的更新: | 05/23/2020 |
最近更新发布: | 05/28/2020 |
实际学习开始日期: | 01/20/2003 |
预计主要完成日期: | 01/20/2021 |
预计完成日期: | 01/20/2022 |
状况或疾病
干预/治疗
Procedure: Antegrade sphincterotomy. ASD.
Device: Antegrade sphincterotomy. ASD.
Procedure: Standard sphincterotomy.
Device: Standard sphincterotomy.
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Standard sphincterotomy. Standard retrograde sphincterotomy is performed on 750 patients using a standard sphincterotome. After deep bile duct cannulation, the standard sphincterotome, the Erlangen "pull-type" model, retrogradely cuts all layers of the wall of the duodenum and sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve insert standard sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis. | Procedure: Standard sphincterotomy. Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct. |
Active Comparator: Antegrade sphincterotomy. ASD. 750 patients underwent a new antegrade sphincterotomy using the new sphincterotome design developed by Dr. Dovbenko (ASD). After deep bile duct cannulation, the new design of sphincterotome, antegradely cuts only circular muscle layer of the sphincter of Oddi. Precut papillotomy using a needle knife used in 20% to improve cannulation new design sphincterotome to bile duct. The number of patients with complications is calculated: bleeding, perforation, pancreatitis, cholangitis, acute cholecystitis, recurrent cholangiolithiasis, restenosis. | Procedure: Antegrade sphincterotomy. ASD. Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: Clinical diagnosis of Gallstone Disease. Must have anatomy of the esophagus of the stomach and duodenum for the introduction of a duodenoscope to the major duodenal papilla. Exclusion Criteria: The acute form of viral hepatitis of any etiology. Acute decompensated heart failure complicated by respiratory failure. |
结果
主要结果指标
1. The number of participants with the complete removal of stones from bile ducts. [During the procedure.]
2. The number of participants with acute pancreatitis. [Up to 12 hours after the procedure.]
3. The number of participants with acute bleeding. [From during the procedure to two days after the procedure.]
4. The number of participants with perforation of duodenum. [From one to 3 days after the procedure.]
次要成果指标
1. The number of participants with restenosis. [From 1 to 5 years after the procedure.]