Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study

Launched by SHENZHEN SECOND PEOPLE'S HOSPITAL · Sep 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment method called modified Laparoendoscopic Rendezvous (LERV) for patients with choledocholithiasis, which is a condition where stones are stuck in the common bile duct—a tube that carries bile from the liver to the intestine. The researchers want to find out how successful this modified technique is, especially in patients whose bile ducts are not enlarged (less than or equal to 10mm in diameter). They hope to determine if this method could become a standard treatment for those dealing with stones that have formed as a result of gallbladder stones.

To be eligible for this trial, participants should be between 18 and 85 years old, have a diagnosis of choledocholithiasis related to gallbladder stones, and must have good heart and lung function to tolerate the surgery. It's important to note that people with certain conditions, such as severe pancreatitis or large numbers of stones, will not be included. For those who join the trial, they can expect to undergo a combination of laparoscopic (minimally invasive) and endoscopic (using a flexible tube with a camera) procedures, all under general anesthesia. The study is currently recruiting participants, so if you or someone you know fits the criteria, it might be an opportunity to explore a potential new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1、18 years ≤ age \<85 years 2、clinical diagnosis of choledocholithiasis secondary to cholecystolithiasis and middle choledocholithiasis (MCBD) diameter ≤10mm; The diameter of MCBD was based on MRCP measurements. If MRCP could not be performed, CT images were used as reference, and B-ultrasound measurements were used as the standard.
• • 3、 Good cardiopulmonary function, anesthesia evaluation tolerance under general anesthesia laparoscopic + endoscopic surgery.
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• Exclusion Criteria:
• • 1、 Intrahepatic bile duct stones with indications for surgery, and need simultaneous surgery; 2、 Patients with choledocholithiasis \>2 cm or a large number of stones were difficult to remove; 3、 Patients with malignant hepatobiliary and pancreatic tumors or biliary tract malformations; 4、 Severe patients with severe pancreatitis and septic shock before operation; 5、Patients with previous gastric and duodenoscopic surgery history and interruption of gastroduodenal continuity; 6、 Severe partial stenosis of the upper gastrointestinal tract (from the oral cavity to the second duodenum), which is expected to be inaccessible to the duodenoscope.
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