CholelithiasisNCT06038201
Cholecystectomy vs EUS-guided GBD With Stone Removal
A study testing LAMS placement for cholecystostomy and Laparoscopic cholecystectomy in people with Cholelithiasis, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- LAMS placement for cholecystostomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEcuador
- Study dates
- 25 Oct 2023to 2 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >18 years old and <89 years old
- Adult symptomatic patients with gallstones documented by US
- Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an EUS-guided GBD
- Patients or authorized representative give informed consent for endoscopic or surgical approach
Who cannot join
- Patients with hepato-pancreato-biliary diseases other than gallstones (tumors, obstructions, inflammation)
- Patients with acute cholecystitis, cholangitis or choledocholithiasis.
- Patients with gallbladder polyps, family history of gallbladder cancer, or any other high-risk factor for gallbladder cancer
- Patient unable to give informed consent or refuse to participate.
- Prior biliary intervention
- Pregnancy or nursing
- Any other medical condition that contraindicates surgical or endoscopic procedures
Trial locations and contacts
1 site in 1 country.
Ecuador1 site, 1 recruiting
- Recruiting
Instituto Ecuatoriano de Enfermedades Digestivas
Guayaquil, Guayas, 090505
Carlos Robles-Medranda, MD, FASGE, +59342109180, carlosoakm@yahoo.es
Carlos Robles-Medranda, MD
About this study
Official title: Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance
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.
Read the detailed description
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.
- Conditions
- Cholelithiasis
- Being tested
- LAMS placement for cholecystostomy, Laparoscopic cholecystectomy
- Keywords
- Cholelithiasis, biliary, cholecystostomy, laparoscopic, cholecystectomy, gallstones
- Medical subject headings
- Cholelithiasis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAMS placement for cholecystostomyProcedure or surgery
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).
Laparoscopic cholecystectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-GBD with stone clearance | Experimental | 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. Receives: Procedure: LAMS placement for cholecystostomy |
| Elective laparoscopic cholecystectomy | Active comparator | Patients >18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success after surgical and endoscopic intervention
Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Measured: Up to 6 hours
Resolution of biliary symptoms
Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Measured: up to 12 months
Adverse events after the surgical procedures
The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Measured: 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
Measured: Up to 14 days
Secondary outcomes (2)
30-day major complications assessment
To assess the safety of the procedures the investigators will consider the 30-day major complication rate
Measured: up to 30 days
Re-intervention rate
Number of patients that requires a re-intervention after an endoscopic or surgical procedure
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start25 Oct 2023
- Primary completion2 Oct 2024 (estimated)
- Study completion2 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A controlled, non-inferiority prospective trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades Digestivas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Robles-Medranda, Instituto Ecuatoriano de Enfermedades Digestivas
- Investigators
- Carlos Robles-Medranda, MD, FASGE, Principal investigator, Instituto Ecuatoriano de Enfermedades Digestivas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038201
- Sponsor's protocol ID
- IECED-10022023
- Status last verified
- Mar 2024
- First submitted
- 30 Aug 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamarajah SK, Karri S, Bundred JR, Evans RPT, Lin A, Kew T, Ekeozor C, Powell SL, Singh P, Griffiths EA. Perioperative outcomes after laparoscopic cholecystectomy in elderly patients: a systematic review and meta-analysis. Surg Endosc. 2020 Nov;34(11):4727-4740. doi: 10.1007/s00464-020-07805-z. Epub 2020 Jul 13.
PubMed 32661706Radlinski MJ, Strand DS, Shami VM. Evolution of interventional endoscopic ultrasound. Gastroenterol Rep (Oxf). 2023 Jun 30;11:goad038. doi: 10.1093/gastro/goad038. eCollection 2023.
PubMed 37398926Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.
PubMed 28028405Du QC, Wang YY, Hu CL, Zhou Y. Reconsideration of indications for choledochoscopic gallbladder-preserving surgery and preventive measures for postoperative recurrence of gallstones. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):87-96. doi: 10.5114/wiitm.2019.88647. Epub 2019 Oct 17.
PubMed 32117490Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.
PubMed 34677160
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholelithiasis Management: Elective Laparoscopic Cholecystectomy vs EUS-guided Gallbladder Cholecystostomy for Gallstones Clearance
- ClinicalTrials.gov ID
- NCT06038201
- Acronym / sponsor ID
- IECED-10022023
- Conditions
- Cholelithiasis
- Keywords
- Cholelithiasis, biliary, cholecystostomy, laparoscopic, cholecystectomy, gallstones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Instituto Ecuatoriano de Enfermedades DigestivasUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 2 Oct 2024 (estimated)
- Study completion
- 2 Nov 2024 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A controlled, non-inferiority prospective trial
| Arm | Type | Receives |
|---|---|---|
| EUS-GBD with stone clearance | Experimental | Procedure: LAMS placement for cholecystostomyPatients >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. |
| Elective laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyPatients >18-year-old with a diagnosis of gallstones by abdominal ultrasound are randomly allocated to elective laparoscopic cholecystectomy and laparoscopic biliary exploration. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >18 years old and <89 years old
- Adult symptomatic patients with gallstones documented by US
- Subject is a suitable candidate for an elective laparoscopic cholecystectomy or an EUS-guided GBD
- Patients or authorized representative give informed consent for endoscopic or surgical approach
Key exclusion criteria (7 listed)
- Patients with hepato-pancreato-biliary diseases other than gallstones (tumors, obstructions, inflammation)
- Patients with acute cholecystitis, cholangitis or choledocholithiasis.
- Patients with gallbladder polyps, family history of gallbladder cancer, or any other high-risk factor for gallbladder cancer
- Patient unable to give informed consent or refuse to participate.
- Prior biliary intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAMS placement for cholecystostomyThe 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). | Procedure or surgery | EUS-GBD with stone clearance |
| Laparoscopic cholecystectomyA 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. | Procedure or surgery | Elective laparoscopic cholecystectomy |
Primary outcome
Technical success after surgical and endoscopic intervention
Time frame: Up to 6 hours
Number of patients with correct placement LAMS or uneventful competition of laparoscopic cholecystectomy along with stone clearance.
Resolution of biliary symptoms
Time frame: up to 12 months
Number of patients with clinical resolution based in a questionnaire for the assessment of biliary symptoms.
Adverse events after the surgical procedures
Time frame: up to 14 days
The post-surgical adverse events will be assessed by the Clavien-Dindo classification
Adverse events after the endoscopic procedures
Time frame: Up to 14 days
The post-endoscopic adverse events will be assessed by the Adverse Events Gastrointestinal Endoscopy (AGREE) Classification
2 secondary outcomes
30-day major complications assessment
Time frame: up to 30 days
Re-intervention rate
Time frame: 12-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 32661706Kamarajah SK, Karri S, Bundred JR, Evans RPT, Lin A, Kew T, Ekeozor C, Powell SL, Singh P, Griffiths EA. Perioperative outcomes after laparoscopic cholecystectomy in elderly patients: a systematic review and meta-analysis. Surg Endosc. 2020 Nov;34(11):4727-4740. doi: 10.1007/s00464-020-07805-z. Epub 2020 Jul 13.
- Background: PubMed 37398926Radlinski MJ, Strand DS, Shami VM. Evolution of interventional endoscopic ultrasound. Gastroenterol Rep (Oxf). 2023 Jun 30;11:goad038. doi: 10.1093/gastro/goad038. eCollection 2023.
- Background: PubMed 28028405Radunovic M, Lazovic R, Popovic N, Magdelinic M, Bulajic M, Radunovic L, Vukovic M, Radunovic M. Complications of Laparoscopic Cholecystectomy: Our Experience from a Retrospective Analysis. Open Access Maced J Med Sci. 2016 Dec 15;4(4):641-646. doi: 10.3889/oamjms.2016.128. Epub 2016 Nov 9.
- Background: PubMed 32117490Du QC, Wang YY, Hu CL, Zhou Y. Reconsideration of indications for choledochoscopic gallbladder-preserving surgery and preventive measures for postoperative recurrence of gallstones. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):87-96. doi: 10.5114/wiitm.2019.88647. Epub 2019 Oct 17.
- Background: PubMed 34677160Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Robles-Medranda, MD, FASGE principal investigator
Instituto Ecuatoriano de Enfermedades Digestivas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAMS placement for cholecystostomy and Laparoscopic cholecystectomy in people with Cholelithiasis, run by Instituto Ecuatoriano de Enfermedades Digestivas at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Robles-Medranda, MD, FASGE (+59342109180, carlosoakm@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success after surgical and endoscopic intervention (time frame: Up to 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06038201, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.