Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
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|ClinicalTrials.gov Identifier: NCT03937037|
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stone - Biliary||Procedure: Saline irrigation||Not Applicable|
In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main reason of stone recurrence is incomplete CBD stone clearance including remnant stone fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It is difficult to retrieve these fine fragments completely using conventional devices such as retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone fragments by means of saline infusion. Saline irrigation has many advantages such as better effect and less side effect and no extra cost. It is reported that use intraductal ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains widespread acceptance because of its independent washing channels and direct viewing.
The purpose of this study is to evaluate whether saline solution irrigation would decrease the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Intermittent Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP|
|Actual Study Start Date :||May 10, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Saline irrigation
CBD stone removal after routine ERCP procedure,100ml saline irrigation after a balloon occlusion cholangiogram confirming the absence of stones.
Procedure: Saline irrigation
100ml saline irrigation after CBD stone removal with routine ERCP procedure
No Intervention: None saline irrigation
CBD stone removal after routine ERCP procedure, a balloon occlusion cholangiogram confirms the absence of stones.
- Number of Participants with Recurrence of CBD Stones [ Time Frame: 3 years ]Number of Participants with stones detected by Magnetic resonance cholangiopancreatography, CT or US confirms CBD stone recurrence no matter symptomatic choledocholithiasis or not
- Number of Participants with Cholangitis [ Time Frame: 3 years ]Temperature should be more than 38 ℃, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal
- Number of Participants with Pancreatitis [ Time Frame: 3 years ]Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after surgery, and there are also radiographic evidence suggesting the shape of pancreas has changed
- Number of Participants with Bleeding [ Time Frame: 1 month ]Was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl
- Number of Participants with Perforation [ Time Frame: 1 month ]Was defined as the presence of air or contrast in the retroperitoneal space
- Procedure time of each case [ Time Frame: 7 days ]From the moment the endoscope entered, to the moment withdraw the scope
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937037
|Contact: Wenbo Meng, MD,PhDemail@example.com|
|Contact: Yudong Wang, MDfirstname.lastname@example.org|
|Hepatopancreatobiliary Surgery Institute of Gansu Province||Recruiting|
|Lanzhou, Gansu, China, 730000|
|Contact: Wenbo Meng, MD,PhD +8613919177177 email@example.com|
|Principal Investigator:||Wenbo Meng, MD,PhD||Hepatopancreatobiliary Surgery Institute of Gansu Province|