An interventional study of LAMS placement for cholecystostomy and Laparoscopic cholecystectomy in Cholelithiasis, sponsored by Instituto Ecuatoriano de Enfermedades Digestivas. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Instituto Ecuatoriano de Enfermedades Digestivas · Not applicable, Interventional, and Treatment
In this new era of less invasive procedures, the indications for endoscopic ultrasound (EUS)-guided gallbladder drainage (GBD) are rapidly expanding. Nowadays, the standard treatment for uncomplicated cholelithiasis (symptomatic patients not requiring hospital admission or non-surgically managed during one or more hospital admissions) is elective laparoscopic cholecystectomy.
To avoid the complications, difficulties and disadvantages of cholecystectomy, the investigators proposed a single-center study to determine the safety and effectiveness of EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone removal in patients with cholelithiasis, in comparison with the gold standard treatment, the elective laparoscopic cholecystectomy.
Currently, elective laparoscopic cholecystectomy (LC), is the preferred management for cholelithiasis in patients with history of gallstones-related adverse events, increased risk for gallbladder cancer, or recurrent typical biliary colic. Although elective LC is a commonly performed surgery, the incidence of serious adverse events is around 2.6%. Also, post-cholecystectomy syndrome, alkaline reflux gastritis and bile duct injury are chronic and feared adverse events secondary to gallbladder removal. To avoid them, a more conservative approach need to be address. The preservation of the gallbladder permits the conservation of its physiological functions, preventing LC adverse events, with potential less recovery time.
In this scenario, the endoscopic ultrasound (EUS) with lumen-apposing metal stent (LAMS)-assisted cholecystostomy for gallstones clearance has gained popularity due its trend toward an improved safety profile. The increased on advanced endoscopy experience along with the development of new stents, tools, and delivery systems, had placed the EUS-guided cholecystostomy as a plausible alternative to elective LC for acute cholecystitis, high-risk surgical patients, or patients with a concomitant bile duct neoplasia. In those contexts, EUS-guided cholecystostomy has demonstrated similar or even less hospitalization length of stays, adverse events, readmissions and reinterventions in comparison with elective LC or percutaneous drainage, respectively. Thus, the feasibility of EUS-guided cholecystostomy for cholelithiasis deserves to be explored.
This study pursues to compare between the effectiveness and safety of EUS-guided cholecystostomy and the elective laparoscopic cholecystectomy through an interventional, two group assignment, controlled trial.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 56 is below the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Instituto Ecuatoriano de Enfermedades Digestivas is the lead sponsor of 39 studies on the registry; 10 are open to participants now.
Compared within Gallstones, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholelithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Patients \>18-year-old with a diagnosis of gallstones by abdominal ultrasound, will be randomly allocated to EUS-guided GBD with electrocautery-enhanced lumen-apposing metal stent (LAMS) (Boston Scientific, Marlborough, MA, EEUU) with stone clearance.
Procedure: LAMS placement for cholecystostomy
Patients \>18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration.
Procedure: Laparoscopic cholecystectomy
The EUS-guided cholecystostomy entails placing a 10 mm x 10 mm or 10mm x 15mm Electrocautery-Enhanced LAMS for direct cholecystoscopy with a transnasal gastroscope. Then, the cholecystostomy will be performed with an echoendoscope, assisted by fluoroscopy to allow the puncturing of the gallbladder form either the duodenal bulb (cholecysto-duodenoscopy) or the gastric antrum (cholecysto-gastrostomy). Subsequently, from the most optimal anatomic point it will be tutored with a 10mmx10mm or 10mm x 15mm LAMS to create anastomosis between the structures. Then, the stone clearance will be performed by endoscopy (basket catheters) or by cholangioscopy (mechanical lithotripsy with or without basket catheters).
A laparoscopic biliary exploration along with an elective laparoscopic cholecystectomy will be performed by experienced laparoscopic surgeons (over 100 laparoscopic procedures yearly) by three or four-trocar technique with transection of the cystic duct and artery.
Technical success after surgical and endoscopic intervention
Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Time frame: Up to 6 hours
Resolution of biliary symptoms
Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Time frame: up to 12 months
Adverse events after the surgical procedures
The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Time frame: up to 14 days
Adverse events after the endoscopic procedures
The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification
Time frame: Up to 14 days
30-day major complications assessment
To assess the safety of the procedures the investigators will consider the 30-day major complication rate
Time frame: up to 30 days
Re-intervention rate
Number of patients that requires a re-intervention after an endoscopic or surgical procedure
Time frame: 12-month follow-up
Plan to share: No
Started Oct 2023 (actual). Primary completion is estimated for Oct 2024, 11 months after the start.
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 11 months is below 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.
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Instituto Ecuatoriano de Enfermedades Digestivas