Left Lateral Position and Prone Position for Endoscopic Retrograde Cholangiopancreatography
Ключови думи
Резюме
Описание
Methods
1. Written informed consent for the endoscopic retrograde cholangiopancreatography is obtained from all patients.
2. Blood culture is performed, and intravenous 3rd generation cephalosporin is administered routinely.
3. Before endoscopic procedure, patients are randomly assigned to left lateral position or prone position for the endoscopic retrograde cholangiopancreatography.
4. Conscious sedation is performed by non-anesthesiologist-assisted method. Intravenous midazolam 0.05-0.1 mg/kg and/or intravenous propofol 0.5mg-1mg/kg is administered. Analgesics was administered intravenous meperidine 25mg in patients with older than 50 years and meperidine 50mg in patients with younger than 50 years. To limit duodenal peristalsis hyoscine-N-butylbromide is administered intravenously.
5. All patients are provided oxygen 2liter/minute via nasal prong. Patient's oxygen saturation, heart rate, blood pressure and respiration are monitored during procedure.
6. Selective bile duct cannulation is performed by wire-guided cannulation method. If adverse event is occur during endoscopic procedure, it is recorded in the case report form as intra-procedural adverse event.
7. After 4 hours, 24 hours, 2 weeks and 6 weeks of the procedure, white blood cell count, hemoglobin, platelet count, total bilirubin, aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma glutamyl transaminase, amylase, lipase, abdomen X-ray, chest X-ray are performed.
8. Oral feeding is started with sips of water after 24 hours of endoscopic sphincterotomy and/or endoscopic papillary balloon dilation.
9. Development of adverse event including bleeding, perforation, pancreatitis, hyperamylasemia, infection, basket impaction, cardiopulmonary adverse event, mortality are recorded according to left lateral position or prone position for the endoscopic retrograde cholangiopancreatography.
Дати
| Последна проверка: | 03/31/2016 |
| Първо изпратено: | 10/31/2015 |
| Очаквано записване подадено: | 10/31/2015 |
| Първо публикувано: | 11/02/2015 |
| Изпратена последна актуализация: | 04/05/2016 |
| Последна актуализация публикувана: | 04/06/2016 |
| Действителна начална дата на проучването: | 07/31/2015 |
| Приблизителна дата на първично завършване: | 03/31/2016 |
| Очаквана дата на завършване на проучването: | 03/31/2016 |
Състояние или заболяване
Интервенция / лечение
Procedure: Endoscopic retrograde cholangiopancreatography
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Left lateral position Endoscopic retrograde cholangiopancreatography is performed in left lateral position in this group. | |
| Active Comparator: Prone position Endoscopic retrograde cholangiopancreatography is performed in prone position in this group. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 20 Years Да се 20 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - All of followings: 1. Any of following indications for ERCP ① Common bile duct stone ② Gallstone pancreatitis ③ Obstructive jaundice due to malignancy (ex. Pancreas cancer, bile duct cancer, ampulla of Vater cancer) ④ Common bile duct invasion metastasis of other organ malignancy (ex. Hepatocellular carcinoma with bile duct invasion, metastatic lymphadenopathy with bile duct invasion from malignancy other than pancreaticobiliary malignancy) ⑤ Benign biliary stricture 2. Naïve papilla 3. Aged over 20 years Exclusion Criteria: - Any of followings: 1. History of endoscopic retrograde cholangiopancreatography 2. Altered gastric and duodenal anatomy due to intra-abdominal surgery (ex. Billroth gastrectomy, total gastrectomy) 3. Patients with severe infection or hemodynamic unstable (ex. septic shock, intubation, ventilator, inotropics) 4. Recent myocardial infarction (within 6 months) or uncontrolled arrhythmia, unstable angina, or congestive heart failure 5. Severe neurologic disease 6. Patients with possible prone position (ex. severe abdominal pain, severe abdominal distension, large amount of ascites, recent intra-abdominal surgery, neck surgery, intra-abdominal catheter insertion, severe obesity) |
Резултат
Първични изходни мерки
1. success in selective bile duct cannulation [within first 1 hour after attempt of bile duct cannulation]
Вторични изходни мерки
1. endoscopic retrograde cholangiopancreatography-related adverse event [within 14 days after endoscopic retrograde cholangiopancreatography]
