EfficacyETGBDNCT05935969
ETGBD in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis
An observational study of Efficacy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Efficacy
- What is being tested?
- ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage)
- Type of treatment
- Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2022to 1 May 2023
- Phase
- Observational
- 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 20 years and older
- All sexes
- Adult, Older adult
Study population: From January 2010 to March 2022, 302 patients with both choledocholithiasis and cholecystolithiasis who were at high surgical risk, were reviewed retrospectively. All 302 patients were initially treated with endoscopic CBD stone removal.
Who may be able to join
- age ≥20 years (ii) presence of choledocolithiasis and cholecystolithiasis on imaging studies (iii) surgically unfit for cholecystectomy.
Who cannot join
- presence of malignant biliary obstruction (ii) follow-up of less than 1 month (iii) previous EST status (iv) pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Transpapillary Gallbladder Drainage for Prevention of Biliary Complication in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis
Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.
Read the detailed description
Gallstones affect 10-15% of the adult population, and 10-25% of them may develop biliary pain or complications. Patients with symptomatic gallstones often have a concomitant CBD stone in 10-20% of them. Most gallstones do not require invasive treatment due to their benign natural history, but CBD stones should be removed due to the risk of developing gallstone-related complications such as obstructive cholangitis and acute gallstone pancreatitis. CBD stones result mainly from the migration of gallstones into the bile duct, so the gold standard treatment for gallstones with CBD stones is endoscopic removal of the CBD stone followed by cholecystectomy to prevent recurrent biliary complications, such as calculous cholangitis or acute cholecystitis.
However, patients who were ineligible for surgery due to high-risk conditions, including the elderly, critically ill status, and severe underlying morbidities, may not get the chance to undergo cholecystectomy. Initial nonoperative management with delayed cholecystectomy has been considered as an alternative treatment, but laparoscopic cholecystectomy reduces the rate of major complications compared with percutaneous gallbladder drainage, even in high-risk patients, and outcomes after early laparoscopic cholecystectomy in octogenarians are comparable to younger patients. Despite this evidence, there are still debates among experts for optimal treatment methods for high-risk patients for surgery with symptomatic CBD stone with gallstone, and gallbladder drainage therapy first to perform for stabilization with surgery rather than urgent cholecystectomy in real practice. Therefore, there is still an unmet need for how to prevent recurrence of CBD stones in patients with concomitant gallstones after endoscopic removal of CBD stones.
Nonsurgical cholecystic drainage methods, including percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), and endoscopic transpapillary gallbladder drainage (ETGBD), have been introduced and actively used as a bridge or alternative therapy in patients at high risk for surgery. Several studies have reported the results of its feasibility and efficacy, mainly focusing on the management of patients with acute cholecystitis. However, the evidence for appropriate management considering non-surgical treatments for patients with both CBD stones and gallstones is still limited. This study evaluated the feasibility and efficacy of ETGBD for patients with both CBD stone and gallstones to prevent recurrent biliary complications in patients at high risk for surgery.
- Conditions
- Efficacy
- Being tested
- ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage)
- Keywords
- Endoscopic transpapillary gallbladder drainage, High risk surgery, Gallstone, Common bile duct stone
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage)Procedure or surgery
For transpapillary gallbladder drainage, biliary cannulation was performed with a duodenoscope (JF-260V or TJF-260V; Olympus Optical). After successful deep cannulation of the CBD, we checked the cholangiogram, performed endoscopic sphincterotomy, and removed the CBD stone using a memory basket and/or retrieval balloon. Cholangiography was then performed again to locate the cystic duct orifice, and a guide wire (Jagwire; Boston Scientific, Marlborough, Massachusetts, USA or Visiglide; Olympus, Tokyo, Japan) was inserted into the gallbladder with different types of catheters (standard catheter, pull-sphincterotome, or rotating sphincterotome) under fluoroscopic guidance. After placement of the guide wire into the gallbladder, contrast dye was injected to confirm good entry into the gallbladder. Once the gallbladder was selected and the guidewire was coiled in the GB, a 7Fr 12-15cm double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Winston-Salem, NC) was inserted into the GB.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of biliary complications
The primary outcome measures were biliary complications, including acute cholecystitis, acute cholangitis, recurrence of choledocolithiasis, and biliary colic. The diagnosis of acute cholangitis, acute cholecystitis were based on Tokyo guideline 18.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start1 Aug 2022
- Primary completion1 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hyun Paik, Seoul National University Hospital
- Investigators
- Myeong Hwan Lee, M.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935969
- Sponsor's protocol ID
- 2305-030-1429
- Acronym
- ETGBD
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 7 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the sensitive nature of the subject of this work and also the clinical data used, our healthboard stipulates that raw data should remain confidential and not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Transpapillary Gallbladder Drainage for Prevention of Biliary Complication in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis
- ClinicalTrials.gov ID
- NCT05935969
- Acronym / sponsor ID
- ETGBD / 2305-030-1429
- Conditions
- Efficacy
- Keywords
- Endoscopic transpapillary gallbladder drainage, High risk surgery, Gallstone, Common bile duct stone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 Jul 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.
Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.
Detailed description
Gallstones affect 10-15% of the adult population, and 10-25% of them may develop biliary pain or complications. Patients with symptomatic gallstones often have a concomitant CBD stone in 10-20% of them. Most gallstones do not require invasive treatment due to their benign natural history, but CBD stones should be removed due to the risk of developing gallstone-related complications such as obstructive cholangitis and acute gallstone pancreatitis. CBD stones result mainly from the migration of gallstones into the bile duct, so the gold standard treatment for gallstones with CBD stones is endoscopic removal of the CBD stone followed by cholecystectomy to prevent recurrent biliary complications, such as calculous cholangitis or acute cholecystitis.
However, patients who were ineligible for surgery due to high-risk conditions, including the elderly, critically ill status, and severe underlying morbidities, may not get the chance to undergo cholecystectomy. Initial nonoperative management with delayed cholecystectomy has been considered as an alternative treatment, but laparoscopic cholecystectomy reduces the rate of major complications compared with percutaneous gallbladder drainage, even in high-risk patients, and outcomes after early laparoscopic cholecystectomy in octogenarians are comparable to younger patients. Despite this evidence, there are still debates among experts for optimal treatment methods for high-risk patients for surgery with symptomatic CBD stone with gallstone, and gallbladder drainage therapy first to perform for stabilization with surgery rather than urgent cholecystectomy in real practice. Therefore, there is still an unmet need for how to prevent recurrence of CBD stones in patients with concomitant gallstones after endoscopic removal of CBD stones.
Nonsurgical cholecystic drainage methods, including percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), and endoscopic transpapillary gallbladder drainage (ETGBD), have been introduced and actively used as a bridge or alternative therapy in patients at high risk for surgery. Several studies have reported the results of its feasibility and efficacy, mainly focusing on the management of patients with acute cholecystitis. However, the evidence for appropriate management considering non-surgical treatments for patients with both CBD stones and gallstones is still limited. This study evaluated the feasibility and efficacy of ETGBD for patients with both CBD stone and gallstones to prevent recurrent biliary complications in patients at high risk for surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From January 2010 to March 2022, 302 patients with both choledocholithiasis and cholecystolithiasis who were at high surgical risk, were reviewed retrospectively. All 302 patients were initially treated with endoscopic CBD stone removal.
Key inclusion criteria (1 listed)
- age ≥20 years (ii) presence of choledocolithiasis and cholecystolithiasis on imaging studies (iii) surgically unfit for cholecystectomy.
Key exclusion criteria (1 listed)
- presence of malignant biliary obstruction (ii) follow-up of less than 1 month (iii) previous EST status (iv) pregnancy
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 |
|---|---|---|
| ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage)For transpapillary gallbladder drainage, biliary cannulation was performed with a duodenoscope (JF-260V or TJF-260V; Olympus Optical). After successful deep cannulation of the CBD, we checked the cholangiogram, performed endoscopic sphincterotomy, and removed the CBD stone using a memory basket and/or retrieval balloon. Cholangiography was then performed again to locate the cystic duct orifice, and a guide wire (Jagwire; Boston Scientific, Marlborough, Massachusetts, USA or Visiglide; Olympus, Tokyo, Japan) was inserted into the gallbladder with different types of catheters (standard catheter, pull-sphincterotome, or rotating sphincterotome) under fluoroscopic guidance. After placement of the guide wire into the gallbladder, contrast dye was injected to confirm good entry into the gallbladder. Once the gallbladder was selected and the guidewire was coiled in the GB, a 7Fr 12-15cm double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Winston-Salem, NC) was inserted into the GB. | Procedure or surgery | – |
Primary outcome
Recurrence of biliary complications
Time frame: through study completion, an average of 2 year
The primary outcome measures were biliary complications, including acute cholecystitis, acute cholangitis, recurrence of choledocolithiasis, and biliary colic. The diagnosis of acute cholangitis, acute cholecystitis were based on Tokyo guideline 18.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Due to the sensitive nature of the subject of this work and also the clinical data used, our healthboard stipulates that raw data should remain confidential and not be shared.
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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.
Myeong Hwan Lee, M.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2023. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of biliary complications (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2023.