Cholesafe 1.0

Recommended Performance Standards for Laparoscopic Bile Duct Exploration

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LCBDE as a procedure is within the remit of all UK consultant Upper GI surgeons with adequate training and experience

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As LCBDE training/competence is not currently defined, new unit providers of LCBDE should have attended an accreditation course and receive external mentorship in their initial experience as part of good medical practice.

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Annual audit of outcomes

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If a LCBDE service is available within your hospital, patients should be made aware that laparoscopic bile duct exploration with cholecystectomy is an alternative treatment to 2 stage treatment laparoscopic cholecystectomy + ERCP

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Those patients who have had previous cholecystectomy should have ERCP as the primary treatment option for new presentation of CBD stones

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CBD stones refractory to extraction by ERCP/Spyglass - If LCBDE is not available locally, arrangements should be made for referral of suitable surgical patients to a nearby unit that does, rather than treatment with repeated biliary stents

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Trans-Cystic exploration should be considered as the primary approach (less morbidity) if size of stones and anatomy allow

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Natural history of small CBD stones is unclear- acceptable to treat if clinical indication, presence of deranged liver function tests/pancreatitis/cholangitis

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Bile Duct diameter for choledochotomy should be ≥10mm to limit risk of bile duct stenosis, ≥8mm in a high volume/experienced LCBDE surgeon’s hands

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Choledochotomy should be performed vertically using sharp dissection (not diathermy)

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Bile ducts should be closed primarily and a T tube applied only for a specific indication (defined- unable to clear duct/inflamed bile duct wall/treatment of complication/morbid patient)

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KPIs

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Conversion rates <10%

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Duct clearance rates > 85% (aim for > 90%)

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Bile Leak Rates < 5% (defined as a leak of bile requiring intervention-additional procedure)

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Returns to theatre < 5%

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Readmission rates after elective and emergency cholecystectomy with LCBDE within 30 days <15%

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Overall Morbidity < 15%

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Overall Mortality  < 1%