An interventional study of Modified laparoscopic transcystic biliary drainage in Common Bile Duct Calculi, Acute; Cholecystitis, Choledocholithiasis and Acute Cholecystitis With Obstruction, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
The modified laparoscopic transcystic biliary drainage which we developed in the treatment of cholecystocholedocholithiasis has some advantages over conventional techniques.
Here, a 7-Fr triple-lumen 30-cm central venous catheter was adopted (Arrow International Inc., Pennsylvania, U.S.A.) to replace conventional 5-Fr ureteral catheter, which extended the function of the C-tube.
Then we developed a continued suture and circling manner by the V-Loc closure device (Covidien V-Loc 180 3-0®, Mansfield, MA, US), which simultaneously covered and anchored the C-tube.
Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side. Our modified path could avoid the compression of the C-tube by hepatic margin and hence decrease the dislocation of the C-tube. In addition, the retroperitoneal path may increase adherence development and sinus-tract formation.
More importantly, this path could easily be available when the patient be placed in the prone position for ERCP, which can conveniently facilitate the guidewire passed through the C-tube down to the duodenum to perform postoperative rendezvous technique.
Theoretically, this modified laparoscopic transcystic drainage not only provide safe and effective bile duct drainage, but also provide a convenient access of treatment for postoperatively retained bile duct stones, which may expand the indication of initially laparoscopic operation in the management of cholecysto-choledocholithiasis.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 310 is above the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 7-Fr triple-lumen 30-cm central venous catheter was adopted to replace conventional 5-Fr ureteral catheter. Then we developed a continued suture and circling manner by the V-Loc closure device, which simultaneously covered and anchored the C-tube. Furthermore, the catheter was introduced through the abdominal wall located at 3 cm below the costal margin on the midaxillary line/the posterior axillary line, which was traditionally performed at the point below the midclavicular line on the right side.
Procedure: Modified laparoscopic transcystic biliary drainage
First, a needle was passed through a separate skin puncture wound 3 cm below the costal margin on the midaxillary line/posterior axillary line. Second, a lateral incision into the cystic duct was performed medially to allow insertion and embedding of the catheter. Third, a 7-Fr catheter was introduced through the abdominal wall via the cystic duct into the CBD. Fourth, if the position of the catheter inside the CBD was correct (the end of the tube reached the distal CBD but did not pass the papilla), the lateral incision of the cystic duct was closed by a V-Loc closure device using a single-layered, continuous suture in a circling manner to simultaneously cover and anchor the C-tube. After the procedure, an artificial fistula of 3 to 5 mm in length was formed.
postoperative overall morbidity
All outcome variables will be assessed according to internationally accepted standards if available, that is, the consensus definitions for surgical and medical complications according to the Clavien-Dindo classification.
Time frame: 6 months
bile leakage
Bile leakage is determined according to the definition and grading of severity by the International Study Group of Liver Surgery.
Time frame: 6 months
anchoring time of the C-tube
the consumption of time from needle puncture to ending of C-tube ligation
Time frame: 6 months
average daily drainage volume
the average volume of bile drainage per day
Time frame: 6 months
early dislodgement of C-tube
the dislodgement of C-tube before intended removal.
Time frame: 6 months
Plan to share: No
Start is estimated for Jan 2024; primary completion for Dec 2026, 35 months later.
Of 58 non-industry interventional studies with no phase under Gallstones, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 43. This study's planned 35 months is above that.
Counting every sponsor, half of 58 studies reached it within 20 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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