preGallstep - A Clinical Pilot Trial

Summary

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed.

The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure.

The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial.

We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

Conditions

• Pancreatitis
• Cholangitis
• Cholecystitis; Gallstone
• Jaundice, Obstructive

Interventions

PROCEDURE

LCBDE + LC

Experimental group: Laparoscopic common bile duct exploration (LCBDE) + laparoscopic cholecystectomy (LC) is performed under full anaesthesia. Once the dissection has exposed the cystic a clip or ligature is placed peripherally on the cystic duct. Through an incision in the duct central to the clip or ligature a cholangiogram catheter is introduced into the cystic duct and the cholangiogram is completed. After identification of the bile duct stones and anatomy, a cholangioscope is introduced through the duct incision into common bile duct. The stones are identified visually and removed by Dormia basket. If the stones are very large, they may be partitioned mechanically or by electrohydraulic lithotripsy. In the presence of CBDS wedged in the papilla these stones will be removed and a secondary cholangiogram will be performed. Subsequently, the cholangioscope is taken out. Then the cystic duct is divided and the gallbladder is dissected out from the liver by hook cautery and removed.

PROCEDURE

ERC + LC

Control intervention: (First step) Endoscopic retrograde cholangiography (ERC) is routinely performed in sedation but or in full anaesthesia. ERC is performed with the patient in the supine position. The endoscope is passed down to the second part of the duodenum where the papilla is identified. Cannulation of the papilla and the common bile duct is performed with a papillotome and a guidewire. A cholangiography will confirm the presence, location and size of the CBDS and aims in further choice of extraction method. Stones can be extracted by papillotomy and by either balloon or by a basket. Additional balloon dilation of the papilla, or lithotripsy may be required. If stone extraction is incomplete or if the conditions are unclear a temporary common bile duct stent is placed which has to be removed with additional ERC after 1-2 months (Second step) laparoscopic cholecystectomy is performed after 2-14 days

Sponsors & Collaborators

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Lars Tue Sorensen

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2023-12-31

Completion

2024-03-01

Countries

• Denmark