CLINICAL TRIAL

Laparoscopic Cholecystectomy with Fluorescent Cholangiography for Calculi

Waitlist Available · 18+ · All Sexes · Vancouver, Canada

This study is evaluating whether a fluorescent dye can help surgeons identify important bile duct anatomy during laparoscopic cholecystectomy.

See full description

About the trial for Calculi

Eligible Conditions
Cholecystitis · Pathological Conditions, Anatomical · Pancreatitis · Digestive System Diseases · Cholecystitis, Acute · Calculi · Pancreatitis Gallstone · Gallstones · Gastrointestinal Diseases · Cholangitis · Gallbladder Diseases · Cholelithiasis · Biliary Tract Diseases · Acute Cholangitis · Cholecystolithiasis · Choledocholithiasis

Treatment Groups

This trial involves 2 different treatments. Laparoscopic Cholecystectomy With Fluorescent Cholangiography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laparoscopic Cholecystectomy with Fluorescent Cholangiography
PROCEDURE
Laparoscopic Cholecystectomy with White Light Imaging
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Laparoscopic Cholecystectomy with White Light Imaging
PROCEDURE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Diagnoses of acute cholangitis, choledocholithiasis, and gall stone pancreatitis may be included. However, they must have cleared ducts confirmed via endoscopic ultrasound, ultrasound, ERCP, and/or laboratory investigations.
Ability to understand and follow study procedures and protocols, and provide signed informed consent.
Admission or consultation by the Acute Care Surgery (ACS) service
Diagnosis of acute biliary disease requiring index laparoscopic cholecystectomy
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through participant discharge, an average of 1 week
Screening: ~3 weeks
Treatment: Varies
Reporting: Through participant discharge, an average of 1 week
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through participant discharge, an average of 1 week.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Laparoscopic Cholecystectomy with Fluorescent Cholangiography will improve 1 primary outcome, 4 secondary outcomes, and 2 other outcomes in patients with Calculi. Measurement will happen over the course of Through participant discharge, an average of 1 week.

Adverse events
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Any adverse events associated with the administration or use of ICG fluorescent cholangiography
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Surgeon satisfaction
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Operating surgeons satisfaction (as rated by post-procedural survey) with the utility and feasibility of the modality.
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Procedural complications
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Any complications associated with the cholecystectomy
THROUGH PARTICIPANT DISCHARGE, AN AVERAGE OF 1 WEEK
Operative time
INTRAOPERATIVELY
From the time of opening the skin to the time of closure.
INTRAOPERATIVELY
Rates of conversion
INTRAOPERATIVELY
Rate of conversion to open cholecystectomy.
INTRAOPERATIVELY
Operative success
INTRAOPERATIVELY
Rates of laparoscopic subtotal cholecystectomy and laparoscopic cholecystostomy tube placement.
INTRAOPERATIVELY
See More

Who is running the study

Principal Investigator
P. D.
Prof. Philip Dawe, Clinical Assistant Professor
University of British Columbia

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How serious can calculi be?

We found a low prevalence (1.3%) of concomitant disease in patients with stone formation in this center. Patients with obstructive jaundice and those who have two or more risk factors for stone formation should undergo computed tomography scan.

Anonymous Patient Answer

What causes calculi?

The current findings suggest that urolithiasis is due to a combination of biochemical factors, genetic factors, and environmental factors. The combination of two, three or more factors may account for only 50% to 60% of cases. A detailed evaluation of familial and environmental causes is required to better categorize cases of urolithiasis, with special emphasis on familial urolithiasis.

Anonymous Patient Answer

How many people get calculi a year in the United States?

Approximately 0.15 million people will be diagnosed with a calculus in the first year of this study; most will be between the ages of 20 and 50; the average age of diagnosis for men is 56.4 years; and most will be non-Hispanic white (82%) or Hispanic (12%).

Anonymous Patient Answer

What are common treatments for calculi?

Some calculi present with no symptoms, and management of such incidental findings can be conservative. Symptomatic stones are usually eliminated or impacted with surgery, which may be curative in up to 50% of cases. Surgical treatment may consist of open surgery, endoscopic surgery, or robot-assisted laparoscopic urological surgery. In case of recurrent calculi or when conservative treatment does not suffice, renal extracorporeal shock wave lithotripsy and electroshock lithotripsy have been found to be effective, though the latter is more preferred for larger stones (<2 cm).

Anonymous Patient Answer

Can calculi be cured?

Occurrence of calculi in the urinary tract of patients with rhabdomyolytic calculi can be reduced by careful followup of patients for the treatment of calculi and prompt treatment of abnormal findings. Treatment depends on the composition. Small stones, which might be visible in ultrasonography, should be treated with medical treatments rather than radical surgery.

Anonymous Patient Answer

What are the signs of calculi?

Stones may be painful but only rarely give no pain in most cases. The appearance of calculi on x-rays is also a common finding. Radiography will usually confirm a diagnosis of a calculus (or calculus of the ureter) if there is clinical or other evidence for it.

Anonymous Patient Answer

What is calculi?

Calculi are common in the general population and are a cause of significant morbidity in many geographical areas. They are often asymptomatic. Appropriate diagnostic imaging is an important issue, but guidelines for the investigation of symptomatic patients are non-existent and, in this author's opinion, there is a need for a clinical protocol.

Anonymous Patient Answer

Who should consider clinical trials for calculi?

Data from a recent study of this study found that nearly one third of the patients in this cohort had evidence of significant calcium disease. This information should be considered when deciding which patients should be invited to enroll in an appropriate clinical trial. Inclusion criteria for randomized double-blind clinical trials should be updated to include all patients with evidence of significant calcium disease as they are at greatest risk of poor renal outcome. If randomized controlled trials for calcium stone disease are performed, it is important to incorporate measurements of calcium burden and renal function.

Anonymous Patient Answer

What does laparoscopic cholecystectomy with fluorescent cholangiography usually treat?

LCM has been known to be not only a diagnostic procedure but also a therapeutic modality. This article proposes the view that LCM with cholangiography, which has the right combination of modalities to treat calcular gallstone disease, will be useful in the future.

Anonymous Patient Answer

Is laparoscopic cholecystectomy with fluorescent cholangiography safe for people?

Laparoscopic cholecystectomy with cholangiography is a safe and effective method for the evaluation of bile duct for the purposes of diagnosis or treatment of suspected common bile duct stones.

Anonymous Patient Answer

Is laparoscopic cholecystectomy with fluorescent cholangiography typically used in combination with any other treatments?

Our current practice is to perform cholecystectomies after ERCP using FNAB. Since our experience is limited, this procedure can be performed in the setting of an ERCP in the setting of standardization of methodology and a careful post cholangiographic follow up.

Anonymous Patient Answer

How does laparoscopic cholecystectomy with fluorescent cholangiography work?

Compared with LCG, the laparoscopic approach (LLCG) has shorter onset time and earlier return to normal everyday activities. It is associated with less postoperative pain and shorter postoperative hospital stay. It also enables diagnosis of choledocholithiasis, with consequent avoidance of endoscopic sphincterotomy. The diagnostic accuracy of the technique, especially for intrahepatic cholangiocarcinoma, is similar to that of LCG. The authors recommend LLLCG be performed when patients with symptoms of biliary disease are submitted to cholecystography.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Calculi by sharing your contact details with the study coordinator.