Hepatopancreatobiliary Surgery Institute of Gansu Province
Lanzhou, Gansu, 730000, China
NCT Number: NCT03701009
The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Lanzhou, Gansu, 730000, China
In recent years, ERCP is the standard procedure to remove the bile duct stones. The big stones(>1.2 cm) require additional lithotripsy procedures for complete stone removal. Nevertheless, small stone fragments still remain in the common bile duct when the cholangiogram shows normal. The fragments are too small to be verified. These retained fragments may cause recurrence of stones. Another way to demonstrate residual CBD stones is to use intraductal ultrasonography (IDUS). However, IDUS has limited availability in clinical practice. The single-operator cholangioscopy (SOC)-system Spyglass gains widespread acceptance because of its independent washing channels and direct viewing. The investigators used Spyglass to detect if saline(50 or 100ml) infusion might clear the bile duct fragments after ERCP. Saline irrigation has many advantages such as easy stone removal, no additional cost and rare side effects. The purpose of this study is to evaluate the usefulness of saline solution irrigation in decreasing residual CBD stones.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone 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.
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.
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.
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.
Time frame: 3 months
Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.
Time frame: 3 months
Was defined as the sum of times of all processes of endoscopic procedure.
Hepatopancreatobiliary Surgery Institute of Gansu Province
Other
Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study
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