Modified laparoendoscopic technique for treating bile duct stones
Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study
This study is testing a new way to remove bile duct stones in patients with gallbladder stones to see if it works better than the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Shenzhen Second People's Hospital Academic / other |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05542784 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the success rate and clinical efficacy of a modified laparoendoscopic rendezvous (LERV) technique in patients with choledocholithiasis secondary to gallbladder stones. Over a three-year period, patients with a non-dilated common bile duct will be treated and monitored for outcomes such as stone removal success, operation time, complication rates, and hospital stay duration. The study will compare the modified LERV approach to traditional treatments to determine its potential as a preferred method for this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with a clinical diagnosis of choledocholithiasis and a middle common bile duct diameter of 10mm or less.
Not a fit: Patients with intrahepatic bile duct stones, large or difficult-to-remove stones, or severe underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less invasive treatment option for patients with choledocholithiasis.
How similar studies have performed: While this approach is being evaluated in this study, similar techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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. - 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. -
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yongqiang Zhan, Chief physician
- Email: yqzhan@sina.com
- Phone: 13714096676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.