Saline Irrigation Reduces the Residual Bile Duct Stones During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Stone Clearance Clinical Trial

Official title:

Saline Irrigation Reduces the Residual Bile Duct Stones After ERCP: a Single-arm Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701009
• Other study ID #: Saline irrigation in ERCP
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2020
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the usefulness of saline solution irrigation in decreasing residual common bile duct (CBD) stones.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• ERCP common bile duct stone patients were able to provide written informed consent;

• Size of stone large than 1.2 cm.

Exclusion Criteria:

• Unwillingness or inability to consent for the study;

• Coagulation dysfunction (INR> 1.5) and low peripheral blood platelet count (<50×10^9 / L) or using anti-coagulation drugs;

• Previous ERCP;

• Prior surgery of Bismuth ?, Roux-en-Y and Cholangiojejunostomy;

• Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage or perforation, severe liver disease(such as decompensated liver cirrhosis, liver failure and so on), septic shock;

• Biliary-duodenal fistula confirmed during ERCP;

• Pregnant women or breastfeeding;

• Presence of intrahepatic duct stone;

• Malignancy.

Related Conditions & MeSH terms

• Calculi
• Stone Clearance

Intervention

Procedure:
• CBD stone removal via lithotripsy
Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
• Saline 50ml
If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
• 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.

Locations

Country	Name	City	State
China	Hepatopancreatobiliary Surgery Institute of Gansu Province	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

References & Publications (2)

Ahn DW, Lee SH, Paik WH, Song BJ, Park JM, Kim J, Jeong JB, Hwang JH, Ryu JK, Kim YT. Effects of Saline Irrigation of the Bile Duct to Reduce the Rate of Residual Common Bile Duct Stones: A Multicenter, Prospective, Randomized Study. Am J Gastroenterol. 2018 Apr;113(4):548-555. doi: 10.1038/ajg.2018.21. Epub 2018 Mar 27. — View Citation

Ramchandani M, Reddy DN, Gupta R, Lakhtakia S, Tandan M, Darisetty S, Sekaran A, Rao GV. Role of single-operator peroral cholangioscopy in the diagnosis of indeterminate biliary lesions: a single-center, prospective study. Gastrointest Endosc. 2011 Sep;74(3):511-9. doi: 10.1016/j.gie.2011.04.034. Epub 2011 Jul 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone fragments clearance	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.	3 months
Secondary	Post-ERCP cholangitis	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.	3 months
Secondary	Bleeding	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.	3 months
Secondary	Post-ERCP pancreatitis	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.	3 months
Secondary	Perforation	Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.	3 months
Secondary	The procedure time	Was defined as the sum of times of all processes of endoscopic procedure.	3 months