An interventional study of Two-point method and Conventional PTCS in Hepatolithiasis and Endoscopy, Digestive System, sponsored by Shengjing Hospital. Completed. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Shengjing Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:
① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.
② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.
③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.
The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's enrollment of 157 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
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Exclusion Criteria:
Procedure: Two-point method
Procedure: Conventional PTCS
In the two-point method, the distal end of the drainage tube was passed over the duodenal and intestinal lumen of the common bile duct during PTCD operation. In the process of sinus dilation, guide wire was sent into the intestinal lumen through the drainage tube, and then the drainage tube was inserted into the intestinal lumen with the extract forceps under the duodenoscope in reverse order to drag the drainage tube into the intestinal lumen before being sent into the guide wire.Clamp the guide wire with the access pliers and slowly draw out the guide wire through the mouth. Expand the outer inlet skin.When the skin was 6mm, the epigastric PTCD tube was removed, the percutaneous nephrostomy dilator was placed through the guide wire, and the patient was instructed to be drawn by the assistant.The mouth end of the guide wire, the surgeon pulls the other end of the guide wire, so that the two ends of the guide wire fix in vitro to form a higher tension to Expand the skin.
PTCS can be divided into three steps: PTCD, sinus dilation, and lithotomy. In PTCD, we first performed intraoperative fluoroscopy, and punctured the biliary tract at a relatively straight Angle with the target biliary tract as far as possible. The distal end of the indenture drainage tube was inserted into the duodeno-intestinal cavity through the end of the common bile duct. The PTCD drainage tube was indwelled for 3-5 days.When the sinus was mature, we used dilated sheath tubes to dilate the sinus to 14-18Fr at a time, and used the working channel established by the choledochoscope to carry out net basket stone extraction. If large diameter stones were difficult to be extracted through the net basket, mechanical lithotomy was adopted to solve the problem, and conventional anti-inflammation was adopted in all patients after surgery. Cholangiography or epigastric CT were used to confirm complete removal of the stones after lithotomy.
Technical success rate
Time frame: up to 1 week
Clinical success rate
Time frame: up to 1 week
Stone recurrence rate
Time frame: through study completion, an average of 1 year
Bleeding
Time frame: up to 2 weeks
Liver abscess
Time frame: up to 2 weeks
Cholangitis
Time frame: up to 2 weeks
Bile leakage
Time frame: up to 2 weeks
Pancreatitis
Time frame: up to 2 weeks
Thoracic complication
Time frame: up to 2 weeks
Iatrogenic injury
Time frame: up to 2 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Shengjing Hospital