Cholecystitis, AcuteEUS-DRAINNCT05702775
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis
A study testing Endoscopic treatment group (EUS-GBD group in people with Cholecystitis, Acute, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Endoscopic treatment group (EUS-GBD group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 1 Jul 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient older than 18 years.
- Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
- Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index > 5 and/or Karnofsky < 50 or decision of the patient not to have surgery.
- Signature of the informed consent of the study
Who cannot join
- Operable acute cholecystitis.
- Refusal of the patient to participate in the study.
- Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.
- Ascites.
- Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.
- Patients with decompensated cirrhosis, portal hypertension and/or gastric varices
Show all 11Show fewer
- Coagulopathy with uncorrectable INR>1.5 or thrombocytopenia <50,000/mm3 uncorrectable.
- Other diagnoses on admission (choledocholithiasis, liver abscesses, acute pancreatitis or biliopancreatic neoplasia).
- Hemodynamic instability.
- Baseline ECOG >=4
- Survival expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Jesús Urman, PhD, +(34) 8484422222, jmurmanf@gmail.com
About this study
Official title: Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)
In this project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs.
The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC.
Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.
Read the detailed description
Design
- Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.
- Cost study Patients who meet the inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study. Between the formalization of the request and the endoscopic examination, the informed consent will be completed in accordance with Law 41/2002 on patient autonomy without altering the relationship with your doctor or causing any damage to your health.
Patients will be randomized in non-endoscopic group or in endoscopic drainage group.
Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018.
The duration of antibiotic treatment in undrained patients will be 10 to 14 days as long as the cholecystitis has been cured and it will be 4-7 days after gallbladder drainage (EUS-GBD or PC) as long as the cure has been achieved of cholecystitis.
Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD)will be performed only in the endoscopic treatment arm. The procedure will be performed after at least 6 hours of fasting
- in the first 72 hours after admission
- in a specific endoscopy room with fluoroscopy assistance,
- by endoscopists experienced in endoscopically guided transmural drainage (with experience of more than 25 drainages)
- under direct sedation with propofol The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS).
Until the acute cholecystitis is cured, a daily evaluation of the visual analogue pain scale (VAS), temperature measurement and periodic blood tests will be carried out.
All patients will receive regular analgesia. Acute cholecystitis will be considered cured if the patient remains afebrile (<37.5ºC), with controlled abdominal pain and presents normalization or a decrease in the number of leukocytes > 20%.
Antibiotic treatment will be adjusted based on the results of blood cultures (BC) or bile culture if available.
Percutaneous cholecystostomy (PC) need. Those patients included who present sepsis, or a critical clinical situation that do not respond to conservative treatment or that after 72 hours of antibiotic treatment do not present clinical improvement, gallbladder drainage will be considered.
Patients included in the NE group who present these circumstances will undergo a PC. For patients in the EUS-GB group, an attempt will be made to perform EUS-GB drainage as soon as possible, and if this is not possible, drainage will be performed by PC (whose performance does not preclude subsequent EUS-GBD).
Periodic follow-up visits will be carried out: every month and every six months until the end of the follow-up. The visits will preferably be face-to-face, and when this is not possible, they will be carried out by telephone, especially in institutionalized patients or with serious mobility problems.
During these visits,
- Record of complications associated with the treatment received and record of EBP developed since the last visit (especially the presence of biliary colic that did not require admission or assessment in the emergency room). An interview will be conducted to collect the presence of EBP that have not required admission (such as biliary colic or related pain), recording the type and date of appearance.
- In cases of EUS-GBD in which it is decided not to remove the prosthesis, the normal position of the prosthesis will be confirmed by abdominal ultrasound.
- IGICV Gastrointestinal Quality of Life Index Questionnaire
- Monitoring of adverse effects The data collection will be carried out by the principal investigator or the collaborating investigators using a data collection notebook (CRD) anonymously and dissociated from the clinical information by means of a patient identification code. The information will be transferred from the data collection notebook to a database (Redcap). The database will be protected with a password to which only researchers will have access.
The follow-up variables after discharge will be collected during the scheduled visits or through a telephone interview at the first, sixth and twelfth month of follow-up.
The economic variables and costs will be those offered by the economic management units of each center.
Descriptive analysis. For quantitative variables, the arithmetic mean and standard deviation will be calculated (variables that do not follow a normal distribution will be described as median, minimum, maximum, and interquartile range), and categorical variables will be expressed as percentages and their 95% confidence intervals.
An intention-to-treat analysis will be performed regardless of treatment received after randomization.
A per-protocol analysis will also be performed, including only those subjects in each group in whom the assigned treatment is successfully carried out.
Logistic regression techniques will be performed to evaluate possible confounding factors (admission diagnosis, referral center, admission severity, age, sex, follow-up center).
Given that there may be differences in the time to recurrence in both groups, we will also assess the appearance of recurrences using Cox risk regression models.
Patients will be censored at the time of loss to follow-up or death. Any urgent admission for biliary complications will be considered as an EBP.
The study data will initially be dissociated from the identity of the participant, by means of an ID, by the responsible physician. The relationship between the ID and the identity of the participant will be kept by the research doctors in a file protected with a personal password.
The data will be entered into the database anonymously with the participant's ID, to maintain their anonymity. The database will be password protected and only accessible by researchers.
Patients eligible for our study will undergo an informative interview with a member of the research team, in which the objectives of the study will be explained, permission will be requested for their inclusion in the study, and informed consent will be given for their inclusion. With the acceptance by the patient and the signing of the informed consent.
The benefit for patients that we are looking for with this study is to significantly reduce the risk of readmission due to EBP in patients with acute lithiasic cholecystitis who are not candidates for surgical treatment.
- Conditions
- Cholecystitis, Acute
- Being tested
- Endoscopic treatment group (EUS-GBD group
- Keywords
- Cholecystitis, Non-operable, Endoscopic
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatment group (EUS-GBD groupProcedure or surgery
The placement of a endoscopic drain performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out.
| Study group | Role | What they receive |
|---|---|---|
| Non-endoscopic treatment group (Group NE) | No intervention | Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018, CAL will be classified into three groups according to severity (I,II,III) and empirical antibiotic treatment will be started according to the recommendations of said guideline |
| Endoscopic treatment group (EUS-GBD Group) | Experimental | The procedure will be performed after at least 6 hours of fasting The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Receives: Procedure: Endoscopic treatment group (EUS-GBD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of biliopancreatic events development at one year of follow-up
Biliopancreatic event (BPE): event related to biliary pathology such as acute cholecystitis, acute cholangitis, symptomatic choledocholithiasis, acute pancreatitis mild-moderate, severe acute pancreatitis, biliary colic (complicated or uncomplicated), liver abscess
Measured: 2 years
Secondary outcomes (8)
Proportion of technical success of EUS-GBD and the complications
Describe the proportion of technical success of EUS-GBD and the complications associated with the management of the patients included in the study
Measured: 2 years
Evaluate healing and time to healing of acute cholecystitis
Evaluate healing and time to healing of acute cholecystitis
Measured: 2 years
Evaluate the duration of the index admission
Evaluate the duration of the index admission
Measured: 2 years
Evaluate the duration of antibiotic treatment
Evaluate the duration of antibiotic treatment
Measured: 2 years
Evaluate the need for percutaneous cholecystostomy
Describe the need for percutaneous cholecystostomy in both groups
Measured: 2 years
Evaluate mortality during admission and follow-up in the two treatment groups
Evaluate mortality during admission and follow-up in the two treatment groups
Measured: 2 years
Evaluate the costs of the two treatment strategies: hospital costs of the index admission and the costs generated during the follow-up period related to the biliopancreatic pathology
Evaluate the costs of the two treatment strategies: hospital costs of the index admission and the costs generated during the follow-up period related to the biliopancreatic pathology
Measured: 2 years
Evaluate the digestive symptoms and quality of life of the patients during follow-up
Evaluate the digestive symptoms and quality of life of the patients during follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Oct 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Maria Urman Fernandez, Fundacion Miguel Servet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702775
- Sponsor's protocol ID
- Jesús María Urmán Fernández
- Acronym
- EUS-DRAIN
- Status last verified
- Jan 2023
- First submitted
- 24 Aug 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis: a Multicenter Randomized Clinical Trial (EUS-DRAIN)
- ClinicalTrials.gov ID
- NCT05702775
- Acronym / sponsor ID
- EUS-DRAIN / Jesús María Urmán Fernández
- Conditions
- Cholecystitis, Acute
- Keywords
- Cholecystitis, Non-operable, Endoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 27 Jan 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 project the investigators propose to carry out a clinical trial that compares non-endoscopic treatment of cholecystitis with antibiotics versus endoscopic drainage in non-operable acute cholecystitism (AC), especially focused on the rate of subsequent EBP and recurrence of AC, as well as the impact on the quality of life, also exploring the costs.
The ultimate goal of this project is to generate knowledge and scientific evidence that makes it easier for health professionals to choose the most appropriate strategy for non-operable patients with lithiasic AC.
Ourworking hypothesis is that endoscopic treatment (EUS-GBD) will significantly reduce the number of EBP compared to non-endoscopic treatment in patients with non-operable lithiasic AC.
Detailed description
Design
- Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.
- Cost study Patients who meet the inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study. Between the formalization of the request and the endoscopic examination, the informed consent will be completed in accordance with Law 41/2002 on patient autonomy without altering the relationship with your doctor or causing any damage to your health.
Patients will be randomized in non-endoscopic group or in endoscopic drainage group.
Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018.
The duration of antibiotic treatment in undrained patients will be 10 to 14 days as long as the cholecystitis has been cured and it will be 4-7 days after gallbladder drainage (EUS-GBD or PC) as long as the cure has been achieved of cholecystitis.
Endoscopic ultrasound-guided transmural gallbladder drainage (EUS-GBD)will be performed only in the endoscopic treatment arm. The procedure will be performed after at least 6 hours of fasting
- in the first 72 hours after admission
- in a specific endoscopy room with fluoroscopy assistance,
- by endoscopists experienced in endoscopically guided transmural drainage (with experience of more than 25 drainages)
- under direct sedation with propofol The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS).
Until the acute cholecystitis is cured, a daily evaluation of the visual analogue pain scale (VAS), temperature measurement and periodic blood tests will be carried out.
All patients will receive regular analgesia. Acute cholecystitis will be considered cured if the patient remains afebrile (<37.5ºC), with controlled abdominal pain and presents normalization or a decrease in the number of leukocytes > 20%.
Antibiotic treatment will be adjusted based on the results of blood cultures (BC) or bile culture if available.
Percutaneous cholecystostomy (PC) need. Those patients included who present sepsis, or a critical clinical situation that do not respond to conservative treatment or that after 72 hours of antibiotic treatment do not present clinical improvement, gallbladder drainage will be considered.
Patients included in the NE group who present these circumstances will undergo a PC. For patients in the EUS-GB group, an attempt will be made to perform EUS-GB drainage as soon as possible, and if this is not possible, drainage will be performed by PC (whose performance does not preclude subsequent EUS-GBD).
Periodic follow-up visits will be carried out: every month and every six months until the end of the follow-up. The visits will preferably be face-to-face, and when this is not possible, they will be carried out by telephone, especially in institutionalized patients or with serious mobility problems.
During these visits,
- Record of complications associated with the treatment received and record of EBP developed since the last visit (especially the presence of biliary colic that did not require admission or assessment in the emergency room). An interview will be conducted to collect the presence of EBP that have not required admission (such as biliary colic or related pain), recording the type and date of appearance.
- In cases of EUS-GBD in which it is decided not to remove the prosthesis, the normal position of the prosthesis will be confirmed by abdominal ultrasound.
- IGICV Gastrointestinal Quality of Life Index Questionnaire
- Monitoring of adverse effects The data collection will be carried out by the principal investigator or the collaborating investigators using a data collection notebook (CRD) anonymously and dissociated from the clinical information by means of a patient identification code. The information will be transferred from the data collection notebook to a database (Redcap). The database will be protected with a password to which only researchers will have access.
The follow-up variables after discharge will be collected during the scheduled visits or through a telephone interview at the first, sixth and twelfth month of follow-up.
The economic variables and costs will be those offered by the economic management units of each center.
Descriptive analysis. For quantitative variables, the arithmetic mean and standard deviation will be calculated (variables that do not follow a normal distribution will be described as median, minimum, maximum, and interquartile range), and categorical variables will be expressed as percentages and their 95% confidence intervals.
An intention-to-treat analysis will be performed regardless of treatment received after randomization.
A per-protocol analysis will also be performed, including only those subjects in each group in whom the assigned treatment is successfully carried out.
Logistic regression techniques will be performed to evaluate possible confounding factors (admission diagnosis, referral center, admission severity, age, sex, follow-up center).
Given that there may be differences in the time to recurrence in both groups, we will also assess the appearance of recurrences using Cox risk regression models.
Patients will be censored at the time of loss to follow-up or death. Any urgent admission for biliary complications will be considered as an EBP.
The study data will initially be dissociated from the identity of the participant, by means of an ID, by the responsible physician. The relationship between the ID and the identity of the participant will be kept by the research doctors in a file protected with a personal password.
The data will be entered into the database anonymously with the participant's ID, to maintain their anonymity. The database will be password protected and only accessible by researchers.
Patients eligible for our study will undergo an informative interview with a member of the research team, in which the objectives of the study will be explained, permission will be requested for their inclusion in the study, and informed consent will be given for their inclusion. With the acceptance by the patient and the signing of the informed consent.
The benefit for patients that we are looking for with this study is to significantly reduce the risk of readmission due to EBP in patients with acute lithiasic cholecystitis who are not candidates for surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, low-intervention, superiority clinical trial with parallel groups for the two treatment strategies.
| Arm | Type | Receives |
|---|---|---|
| Non-endoscopic treatment group (Group NE) | No intervention | –Antibiotic treatment will start from the moment of diagnosis in both arms of the study. Following the recommendations of the Clinical Practice Guideline for the Management of Acute Cholecystitis of Tokyo 2018, CAL will be classified into three groups according to severity (I,II,III) and empirical antibiotic treatment will be started according to the recommendations of said guideline |
| Endoscopic treatment group (EUS-GBD Group) | Experimental | Procedure: Endoscopic treatment group (EUS-GBD groupThe procedure will be performed after at least 6 hours of fasting The placement of the drain will be performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient older than 18 years.
- Definitive diagnosis of acute lithiasic cholecystitis according to the GP Tokyo 2018 criteria.
- Surgical decision of inoperable patient (if one or more of the following criteria is met: age ≥80 years, American Society of Anesthesiology (ASA) III or more, Charlson Comorbidity Index > 5 and/or Karnofsky < 50 or decision of the patient not to have surgery.
- Signature of the informed consent of the study
Key exclusion criteria (11 listed)
- Operable acute cholecystitis.
- Refusal of the patient to participate in the study.
- Anatomy of the GI tract altered by previous hepatobiliary or upper GI surgery.
- Ascites.
- Inability to tolerate endoscopy sedation, perforation of the digestive tract, or other contraindication to endoscopy.
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 |
|---|---|---|
| Endoscopic treatment group (EUS-GBD groupThe placement of a endoscopic drain performed using a linear echoendoscope that allows the gallbladder to be punctured from the gastric antrum or the duodenal bulb to generate a cholecystogastrostomy or a cholecystoduodenostomy, respectively. Transmural gallbladder drainage will be performed by placing a metal apposition stent (LAMS) with the 15x15mm Hot AXIOS device (Boston Scientific) in the case of cholecystogastrostomy or 15x10 or 10x10mm in the case of cholecystoduodenostomy. Subsequently, the interior of the gallbladder will be irrigated with saline solution until the vesicular content comes out. | Procedure or surgery | Endoscopic treatment group (EUS-GBD Group) |
Primary outcome
Cumulative rate of biliopancreatic events development at one year of follow-up
Time frame: 2 years
Biliopancreatic event (BPE): event related to biliary pathology such as acute cholecystitis, acute cholangitis, symptomatic choledocholithiasis, acute pancreatitis mild-moderate, severe acute pancreatitis, biliary colic (complicated or uncomplicated), liver abscess
8 secondary outcomes
Proportion of technical success of EUS-GBD and the complications
Time frame: 2 years
Evaluate healing and time to healing of acute cholecystitis
Time frame: 2 years
Evaluate the duration of the index admission
Time frame: 2 years
Evaluate the duration of antibiotic treatment
Time frame: 2 years
Evaluate the need for percutaneous cholecystostomy
Time frame: 2 years
Evaluate mortality during admission and follow-up in the two treatment groups
Time frame: 2 years
Evaluate the costs of the two treatment strategies: hospital costs of the index admission and the costs generated during the follow-up period related to the biliopancreatic pathology
Time frame: 2 years
Evaluate the digestive symptoms and quality of life of the patients during follow-up
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic treatment group (EUS-GBD group in people with Cholecystitis, Acute, run by Fundacion Miguel Servet at 1 site in Spain.
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 11 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 27 Jan 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 Spain. 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 Jesús JU Urmán, PhD (+(34) 8484422222, jmurmanf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rate of biliopancreatic events development at one year of follow-up (time frame: 2 years). 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 27 Jan 2023.