A PROSPECTIVE RANDOMISED CONTROL TRIAL TO EVALUATE THE ROLE OF PROPHYLACTIC OCTREOTIDE IN PREVENTING ERCP INDUCED PANCREATITIS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- % WITH ERCP INDUCED PANCREATITIS ACCORDING TO THE MODIFIED ATLANTA CLASSIFICATION
研究概览
简要总结
Endoscopic retrograde cholangio pancreaticography (ERCP) is avery useful diagnostic and therapeutic modality for Hepatobiliary andPancreatic Pathologies. it is a minimal invasive techniques for diagnosing andtreating various hepatobiliary diseases which demanded major surgicalexplorations in the past. The various complications of this procedure includepancreatitis, hemorrhage, perforation and other pulmonary cardiovascular abnormalities. Pancreatitis is the most commonand the most fearful of all these complications. The various measures includeboth pharmacologic and procedural measures to reduce the incidence of the same.
Amongst thepharmacologic measures various agents have been tried and studied to know whetherthey have a role for preventing pancreatitis. Octreotide, a somatostatinanalogue reduces enzyme release and inhibits activation of pancreatic enzymes.Our study would evaluate the incidence of ERCP induced pancreatitis and wouldfurther establish if prophylactic use of octreotide would reduce the incidenceof post ERCP induced pancreatitis , significantly or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •WILLING TO PARTICIPATE IN THE STUDY
- •UNDERGOING ERCP FOR A VALID INDICATION
- •FOLOOWING UP WITH POST ERCP EVALUATION FOR DIAGNOSING PANCREATITIS.
排除标准
- •PREGNANCY AND LACTATION
- •CHRONIC RENAL FAILURE
- •ACUTE MYOCARDIAL INFARCTION DURING THE LAST 3 MONTHS BEFORE PROCEDURE
- •HIV POSITIVE OR ANY OTHER IMMUNO-COMPROMISED STATE
- •PLANNED BILIARY STENT REMOVAL OR EXCHANGE
- •HISTORY OF ALCOHOL OR OTHER DRUG ABUSE 7.RECENT USE OF NARCOTIC ANALGESIC OR ANTICHOLINERGIC MEDICATION
- •HISTORY OF CHRONIC PANCREATITIS OR OTHER DISEASE KNOWN TO EFFECT PANCREATIC SECRETION (VAGOTOMY, GASTRECTOMY, INFLAMMATION)
- •REFUSAL TO PARTICIPATE
- •PATIENTS WITH PREVIOUS HISTORY OF ERCP INDUCED PANCREATITIS.
结局指标
主要结局
% WITH ERCP INDUCED PANCREATITIS ACCORDING TO THE MODIFIED ATLANTA CLASSIFICATION
时间窗: 48 HOURS THOUGH . The length of hospital stay will be decided by the treating unit under which the patient is admitted. In case, the patient is discharged before 48 hours, he or she will be followed on a telephonic interview basis.
次要结局
未报告次要终点