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Completed

NCT Number: NCT03701009

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatopancreatobiliary Surgery Institute of Gansu Province

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Ⅱ, 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.

Treatment and study plan

CBD stone removal via lithotripsy

Procedure

Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.

Saline 50ml

Procedure

If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.

Saline +50ml

Procedure

If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Perforation

    Time frame: 3 months

    Number of perforation participants who was defined as the presence of air or contrast in the retroperitoneal space.

  5. The procedure time

    Time frame: 3 months

    Was defined as the sum of times of all processes of endoscopic procedure.

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2018
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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