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OpenTrials
Completed

NCT Number: NCT02329977

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones

ERCP is the primary choice for removal of common bile duct stone (CBDS) currently. However, 4-24% patients underwent recurrence after successful clearance of CBDS. Stone re-formation due to chronic inflammation of biliary duct is generally considered an important cause of CBDS recurrence, which is associated with duodenal-biliary reflux (DBR) after sphincterotomy. Although it was believed that DBR was the important cause of CBDS recurrence, the direct evidence was still lacking. Here we conducted a case control study to investigate the DBR rate in patients with recurrent CBDS after ERCP.

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Key information

Conditions

Common Bile Duct Gall Stones Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Common Bile Duct Gallstones Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with common bile duct stone underwent successful stone removal by ERCP in Xijing Hospital of Digestive Diseases.

Exclusion criteria

  • Gallbladder stones or hepatolithiasis;
  • Stenosis of biliary duct;
  • Incomplete common bile duct stone removal by ERCP;
  • Common bile duct stent;
  • Unable to provide informed consent.

Treatment and study plan

standard barium meal examination

Other

All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.

Primary outcomes

  1. Duodenal-biliary reflux rate

    Time frame: up to 6 months

    The proportion of patients with barium reflux into bile duct during the standard barium meal examination.

Secondary outcomes

  1. Distal common bile duct angle

    Time frame: up to 6 months

    MRCP revealed the first angulation from the ampullary orifice along the course of the common bile duct stone.

  2. Maximal CBD diameter

    Time frame: up to 6 months

    Maximal CBD diameter was determined by MRCP.

  3. Peripapillary diverticulum

    Time frame: up to 6 months

    Peripapillary diverticulum was defined endoscopically as the presence of a diverticulum within a 2-cm radius from the papilla and was divided into 2 types in terms of the relation between the papilla and diverticulum: type A, papilla located on the inner rim of the diverticulum or papilla located deep within the diverticulum; and type B, papilla located outside the diverticulum.

  4. Pneumobilia

    Time frame: up to 6 months

    Pneumobilia were determined by CT

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

Rate of Duodenal-biliary Reflux Increases in Patients With Recurrent Common Bile Duct Stones: Direct Evidence From Barium Meal Examination

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jan 1, 2015
Registry last updated
Dec 2, 2015

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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