Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)
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|ClinicalTrials.gov Identifier: NCT03701009|
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : July 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stone Clearance||Procedure: CBD stone removal via lithotripsy Procedure: Saline 50ml Procedure: Saline +50ml||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study|
|Actual Study Start Date :||October 10, 2018|
|Actual Primary Completion Date :||July 1, 2020|
|Actual Study Completion Date :||July 1, 2020|
Stone removal (Saline 50ml each time)
After CBD stone removal via lithotripsy, and the cholangiogram showed normal, residual CBD stones were detected by SpyGlass in the first round, if CBD not clean, sterile saline 50ml were intermittently irrigated into the CBD. After that, if bile duct clearance was not achieved, another 50ml saline will be irrigated into CBD again until the clear bile duct determined by SpyGlass.
Procedure: CBD stone removal via lithotripsy
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
Procedure: Saline 50ml
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
Procedure: Saline +50ml
If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.
- Stone fragments clearance [ Time Frame: 3 months ]Type 1: Not clean, large stone fragments; Type 2: Clusters residue and floccule; Type 3: Small biliary sludge or floccule Type 4: Slightly clean with a small amount of floccule or small residue; Type 5: Clean.
- Post-ERCP cholangitis [ Time Frame: 3 months ]Number of Post-ERCP cholangitis participants, Post-ERCP cholangitis was defined as a temperature of more than 38 °C for 24-48 h after the procedure, thought to have a biliary cause without evidence of other concomitant infections.
- Bleeding [ Time Frame: 3 months ]Number of Bleeding participantsas who was defined as the clinical and endoscopic evidence of hemorrhage associated. with a decreasing the hemoglobin level >2 g/dl.
- Post-ERCP pancreatitis [ Time Frame: 3 months ]Number of Post-ERCP pancreatitis participants who was defined as any new or worsened abdominal pain with an increasing serum. amylase of over three times the upper normal limit that was measured more than 24h after the procedure.
- Perforation [ Time Frame: 3 months ]Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
- The procedure time [ Time Frame: 3 months ]Was defined as the sum of times of all processes of endoscopic procedure.
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): NCT03701009
|Hepatopancreatobiliary Surgery Institute of Gansu Province|
|Lanzhou, Gansu, China, 730000|
|Study Director:||Xun Li, MD,PhD||Hepatopancreatobiliary Surgery Institute of Gansu Province|