Immediate vs. Elective Endoscopic Removal of Large CBD Stones in High-Risk Elderly Patients

The goal of this clinical trial is to compare two different approaches for removing large or multiple stones from the common bile duct in older adults with chronic diseases. The main questions it aims to answer are:

Is it better to remove the stones immediately during the first endoscopic procedure? Or is it safer and more effective to place a temporary plastic stent first and remove the stones later?

Researchers will compare these two approaches to see which one leads to better stone clearance and fewer complications.

Participants will:

Undergo an endoscopic procedure (ERCP) to treat their bile duct stones. Be randomly assigned to either have immediate stone removal or have a stent placed first, with stone removal scheduled 8-12 weeks later.

Attend follow-up visits to monitor their recovery and check for complications.

This study is being conducted at the National Liver Institute, Menoufia University, Egypt.

Choledocholithiasis, or stones in the common bile duct (CBD), is a frequent and potentially serious condition that can cause jaundice, infections, and inflammation of the pancreas. Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) is the preferred method for removing these stones. However, large stones (≥15 mm) and multiple stones (three or more ≥10 mm) present technical challenges, often requiring additional interventions such as mechanical lithotripsy to break the stones into smaller pieces before extraction.

In some cases, complete stone removal is not feasible in a single procedure. One strategy to manage this situation is the placement of a temporary plastic stent, which keeps the bile duct open and allows bile to drain, reducing the risk of complications such as infection. Some studies suggest that stent placement can alter the characteristics of the stones, making them softer and easier to remove in a later procedure. However, delaying stone extraction may increase the risk of stent-related complications, including stent clogging and cholangitis (infection of the bile duct).

This prospective, randomized study aims to compare two approaches for managing large or multiple CBD stones in older adults (aged 65 and above) with significant chronic conditions. These patients are considered high-risk for complications from prolonged or repeated endoscopic procedures. The study evaluates whether immediate stone removal during the first ERCP procedure is more effective and safer than initial stent placement followed by delayed stone retrieval after 8-12 weeks.

Study Design and Methods:

Participants will be randomly assigned to one of two groups:

Group A (Stent-first Approach): Patients will receive a temporary plastic stent during the first ERCP, and stone removal will be planned for a second procedure in 8-12 weeks.

Group B (Stone Retrieval-first Approach): Patients will undergo an immediate attempt at complete stone removal during the first ERCP. If removal is unsuccessful, a stent will be placed as in Group A.

The ERCP procedures will be performed by experienced endoscopists using standard techniques, including sphincterotomy, balloon dilation, and mechanical lithotripsy when necessary. Technical success, procedure duration, and the rate of complete stone clearance will be documented. Patients will receive standard supportive care, including prophylactic antibiotics and rectal indomethacin to reduce the risk of post-ERCP pancreatitis.

Primary and Secondary Outcomes:

The primary outcome of the study is the rate of complete stone clearance without the need for additional procedures. Secondary outcomes include:

The incidence of complications such as pancreatitis, bleeding, or infections.

The duration of the procedure and hospital stay.

The need for repeat ERCP procedures.

The overall impact on patient morbidity and mortality.

Patients will be monitored closely for complications, and follow-up visits will be scheduled at 2 weeks, 1 month, and 3 months after hospital discharge.

Significance of the Study:

This study addresses an important clinical question for the management of CBD stones in high-risk older adults. While immediate stone removal is often preferred, it may increase the risk of complications in frail patients. Alternatively, placing a stent first may allow for easier and safer stone removal in a subsequent procedure but could lead to stent-related issues. The findings of this study will help guide clinical decision-making by determining which approach offers the best balance of efficacy and safety for this vulnerable patient population.

This study is conducted at the National Liver Institute, Menoufia University, Egypt, following ethical guidelines and international clinical trial standards.

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 65 or older and had one or more serious chronic conditions, such as cardiovascular disease, cerebrovascular disease, pulmonary disease, diabetes, or chronic liver or kidney disease (Charlson Comorbidity Index (CCI) ≥ 3) and presence of large CBD stones, defined as a single stone ≥15 mm in diameter or three or more stones each ≥10 mm in diameter, confirmed via computed tomography or magnetic resonance cholangiopancreatography.

Exclusion Criteria:

- Inability to provide informed consent, contraindications to ERCP or general anesthesia, anatomical changes due to biliary surgery, benign or malignant strictures in the distal bile duct, intrahepatic bile duct stones, moderate to severe cholangitis, and malignancies or other serious conditions with a life expectancy of less than six months.