RecruitingACTRN12620000151932

Protocol for choledocholithiasis at emergency surgery study (ProCESS)

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


Sponsor

Rhys Jones FRCS

Enrollment

30 participants

Start Date

Nov 19, 2019

Study Type

Observational

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 85 Yearss

Plain Language Summary

Simplified for easier understanding

Gallstones are very common, and sometimes a stone can escape the gallbladder and get stuck in the main bile duct — the tube that drains bile from the liver into the bowel. This can cause pain, infection, or jaundice, and usually needs urgent treatment. There are several ways doctors can remove the stone, and this study is testing a new approach. The new protocol involves removing the gallbladder by keyhole surgery (laparoscopic cholecystectomy), then placing a small temporary stent (a tube) in the bile duct to keep it open. The patient can then go home and come back later for an endoscopy (a camera test through the mouth) to remove the stone at a convenient time. Researchers want to find out if this approach is safe and improves the patient experience. You may be eligible if you are an adult (under 85) who is having emergency keyhole gallbladder surgery and bile duct stones are found before or during the operation. Pregnant women are not eligible. The trial is designed to make your hospital journey smoother, safer, and less stressful.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12620000151932


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