Clinical trial NCT05542784: Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study
Official title: Modified Laparoendoscopic Rendezvous for Secondary Choledocholithiasis: a Nonrandomized Controlled Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Choledocholithiasis
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 85 years with common bile duct stones who are suitable for and consent to undergo laparoscopic plus endoscopic surgery under general anesthesia

Brief summary: This study intends to explore the success rate and clinical efficacy of modified LERV in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Detailed description: Patients with cholecystolithiasis secondary to common bile duct stones requiring surgical treatment during a 3-year period from 2022-6-1 to 2025-3-31 were enrolled in this non-randomized controlled clinical trial. Preoperative diameter of the middle common bile duct was determined by magnetic resonance cholangiography (MRCP) or B-ultrasound measurement. The actual treatment plan of the patients was recorded, including LERV treatment and ERCP+LC treatment. The baseline data and the success rate of stone removal, operation time, postoperative stone residual rate, complication rate, length of hospital stay and hospitalization cost were recorded for observation and follow-up. To determine whether modified LERV can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

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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Primary outcomes:
measure: Effectiveness evaluation index
timeFrame: intraoperative
Secondary outcomes:
measure: Postoperative related clinical indicators
timeFrame: Blood routine, pancreatic enzyme binomial and liver function were examined on the first and second day after operation.
measure: The hospital indicators
timeFrame: an average 1 week
measure: the incidence of serious complications
timeFrame: Within 1 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Zibing Fan, Attending physician
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Ganchen Sun, Nurse practitioner
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Yanan Bao, nurse-in-charge
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Xuelin Liu, Nurse practitioner
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Haoyuan Deng, Attending physician
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Yifan Zhang, Master's Degree student
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Yang Li, Nurse practitioner
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Haoran Ma, Nurse practitioner
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Naiyang Zhan, Attending physician
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Yiyuan Chen, Master's Degree student
role: STUDY_CHAIR
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