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Protocol for choledocholithiasis at emergency surgery study (ProCESS)

A cohort study to evaluate the protocolised management of bile duct stones in emergency general surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000151932
Acronym
ProCESS
Enrollment
8
Registered
2020-02-13
Start date
2019-11-19
Completion date
2020-03-31
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Gallstone disease is very common, and results in a large number of hospital admissions per year. Some patients with gallstones can develop a blockage in their main bile duct due to stones, which can put them at risk of severe infection, jaundice or other problems like pancreatitis. There are several ways in which surgeons can go about removing the stones from the bile duct, including during surgery or via endoscopy (camera test down the mouth). There is also an option of placing a stent in the bile duct. There is currently no agreement between surgeons on which of these options is the best. We have developed a new protocol to determine if patients can be safely sent home after surgery with a bile duct stent, and then return for an endoscopy electively. We aim to prove that this option is safe, and also improves and steamlines the patient experience.

Interventions

A cohort study to evaluate a management protocol for CBD stones within the Acute General Surgery Unit (AGSU). Outcome data will be recorded from patients with bile duct stones undergoing emergency laparoscopic cholecystectomy. Management of CBD stones: Laparoscopic bile duct exploration can be considered for all patients irrespective of stone size and number. If the surgeon is unwilling or unable to clear the bile duct at the time of cholecystectomy then further management is determined by ston

A cohort study to evaluate a management protocol for CBD stones within the Acute General Surgery Unit (AGSU). Outcome data will be recorded from patients with bile duct stones undergoing emergency laparoscopic cholecystectomy. Management of CBD stones: Laparoscopic bile duct exploration can be considered for all patients irrespective of stone size and number. If the surgeon is unwilling or unable to clear the bile duct at the time of cholecystectomy then further management is determined by stone size and number as well as the presence of absence of biliary obstruction as evidenced by jaundice (bilirubin >40mmol/litre) CBD stone size is estimated with reference to an Olsen-Reddick laparoscopic grasper (width 4.5mm). Group A: Solitary stones < 4.5mm with no biochemical evidence of biliary obstruction Laparoscopic bile duct exploration or conservative management of CBD stones, at the discretion of the operating surgeon. Group B: Stones > 4.5mm, multiple stones or biochemical evidence of biliary obstruction CBD exploration or transcystic stenting at the discretion of the operating surgeon. Exploration may be performed via the transcystic (through the cystic duct) or transductal (via incision into the CBD) route, with or without choledochoscopy. Positioning is checked by intraoperative x-ray. With good stent positioning and biliary drainage, patients may be discharged postoperatively without further investigation or treatment and booked for an elective ERCP. We expect the elective ERCP to be booked within 4-6 weeks of discharge, and our time of follow up ends after successful bile duct clearance via ERCP. This protocol will be undertaken in the unit regardless of the study occurring, as this is already in line with standard practice for many of the surgeons.

Sponsors

Rhys Jones FRCS
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

All consecutive patients within unit undergoing emergency laparoscopic cholecystectomy with bile duct stones identified pre or intra-operatively

Exclusion criteria

Pregnancy Age >85 years

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026