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Completed

NCT Number: NCT04467710

Laparoscopic Treatment of Common Bile Duct Stones : What Are the Limits and When Should we Call the Endoscopist ?

The aim of this study was to identify some risk factors of failure of surgical management of common bile duct stones, in our center between 2007 and 2019.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

Lithiasis disease represents a real public health problem. Indeed, 10% of the general population is asymptomatic carrier of gallbladder stones and among them, 35% will present a symptomatic form which will cause the indication of cholecystectomy. As a result, around 120,000 cholecystectomies are performed per year in France, and around 750,000 in the United States for this indication. Cholecystectomy is therefore the most widely performed procedure in the world. However, in 3 to 20% of cases, common bile duct stones will be associated and to be treated. Different strategies are proposed: a treatment called "all surgical" or an endoscopic treatment (usually a sphincterotomy) before, after or during a cholecystectomy. The investigators defined two groups of patients: one group with success of fully laparoscopic surgical treatment (cholecystectomy and laparoscopic exploration of the common bile duct at the same time), and one group treated by laparoscopic cholecystectomy and management of the common bile duct stone(s) by an ERCP performed intra, per ou postoperatively. The primary outcome was the failure of surgical management, defined as the requirement of ERCP for extraction of common bile duct stones, which permit us to identify risk factors of failure in the fullfil surgical treatment process. The secondary outcome was to study the morbimortality in each group, and length of stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • More than 18 years old
  • Between 2007 and 2019
  • Montpellier University Hospital
  • Laparoscopic cholecystectomy for symptomatic cholelithiasis associated to common bile duct stones
  • Common bile duct stones highlighted on preoperative imaging or intraoperative cholangiography
  • Common bile duct stones treated during the same hospital stay surgically or endocopically

Exclusion criteria

  • Laparotomy
  • Previous ERCP
  • Less than 18 years old
  • Lost to follow up
  • Lack of data > 10%
  • Other surgical procedure associated at the same time
  • Previous cholecystectomy
  • Caroli's disease
  • Severe cholangitis or acute pancreatitis
  • Pigmentary or hydatic lithiasis
  • Laparoscopic cholecystectomy for other indication than symptomatic cholelithiasis

Treatment and study plan

Laparoscopic common bile duct exploration.

Procedure

Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct.

ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time.

Primary outcomes

  1. morbimortality

    Time frame: 1 day

    Clavien dindo classification

Secondary outcomes

  1. risk factors of total laprascopic treatment failure.

    Time frame: 1 day

    risk factors of total laprascopic treatment failure.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Treatment of Common Bile Duct Stones in a Laparoscopic Center : What Are the Limits and When Should we Call the Endoscopist ? Observationnal Study Between 2007-2019

Important dates

Study start
2007
Primary completion
2019
Study completion
2020
First posted
Jul 13, 2020
Registry last updated
Sep 3, 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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