Effects of Pre-procedure and Intra-procedure Simethicone and Dicyclomine Administration in Improving Quality of Endoscopic Reterograde Cholangipancreaticography (ERCP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Duodenal Motility
研究概览
简要总结
Endoscopic Reterograde Cholangiopancreatography is widely used to diagnose and treat hepatobiliary disorders. Ampullary cannulation is an essential step and good mucosal visibility improves procedural efficiency.
Objective of the study: Our study aims to investigate the effects of Pre-procedural and intra-procedural administration of Semithicone as a defoaming agent and Dicylomine in reducing duodenal contractions.
Methodology: A randomized, double blind, controlled, trial will be conducted at Combined Military Hospital, Lahore after obtaining informed consent. Data will be prospectively collected over a period of 6 months. Patients will be randomized into three groups using block randomization and split into 3 groups i.e: Group 1: control (no intervention), Group 2: Pre procedural semithicone administration and Group 3: intraprocedural administration. Mucosal visibility and duodenal motility will be assessed using a scale. Procedure time and endoscopists' satisfaction will be inquired.
详细描述
Study design: This is a randomized, double blind, controlled, trial which will be commenced after ethical approval by the institutional review board at Combined Military Hospital, Lahore. Written informed consent of all participants will be sought. Data will be prospectively collected over a period of 6 months.
Participants: Patients older than 18 years of age, presenting to the Gastroenterology department for an ERCP will be enrolled. Cases that are abandoned due to inability to access the ampulla will be excluded. Patients with grossly altered anatomy resulting in extended procedure time will also excluded.
Study Protocol: Patients will randomly assigned to one of three groups at presentation: The control group (Group 1), the pre-procedure treatment group (Group 2) and the intraprocedural treatment group (Group 3).
Patients will be randomized into three groups using block randomization. A 1:1:1 block randomization technique will be used with block sizes of 6. The random allocation sequence is generated using the randomization website https://www.sealedenvelope.com. A designated nurse shall allot the patients into the specific groups.
All procedures will be performed by two experienced endoscopists (MH and RD) using a side viewing duodenoscope. Each biliary cannulation will be attempted using a sphincterotome and 0.035" guidewire. Still images and high-quality videos will be recorded during the procedure and examined at the end of the procedure by a Hepatology fellow (MS) who is blinded to the treatment arm. The fellow shall grade the mucosal visibility and duodenal contractility using scales employed by previous studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients presenting for ERCP older than 18years of age.
- •Patients willing to participate in the study, meeting criteria No. 1
排除标准
- •Cases that are abandoned due to inability to access the ampulla
- •Patients with grossly altered anatomy resulting in extended procedure time
研究组 & 干预措施
Control
干预措施: Control (Other)
Pre Procedural Group
- Oral Semithicone 40mg + Dicyclomine 1mg (30min before procedure)
- Intraprocedural water Spray
干预措施: Preprocedural (Drug)
Intraprocedural
- Oral Water 30mL (30min before procedure)
- Simethicone+ Dicylomine spray
干预措施: Intraprocedural (Drug)
结局指标
主要结局
Duodenal Motility
时间窗: From enrollment to end of the procedure i.e.: approximately 25 minutes
The duodenal motility was graded as follows (0) No contractions were observed. 1. \<5 contractions per minute were observed. 2. 5 to 10 contractions per minute were observed. 3. 11 to 15 contractions per minute were observed. 4. Continuous contractions were observed.
Mucosal Visibility
时间窗: From enrollment to end of the procedure i.e.: approximately 25 minutes
assessed using a 4 point scale as follows (0) No bubbles-the procedure could be easily performed. 1. Very few bubbles-this did not interfere with the procedure. 2. A slightly greater quantity of bubbles-the procedure could be performed with some difficulty. 3. A large quantity of bubbles interfering with the procedure-accurate evaluation was impossible.
次要结局
- Endoscopists Satisfaction(From enrollment to end of the procedure i.e.: approximately 25 minutes)
- Time of the procedure(Total procedural length approximately 25 to 45 minutes)
研究者
Ayesha Malik
Principal investigator
CMH Lahore Medical College and Institute of Dentistry