Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05702775
Status:
RECRUITING
Last Update Posted:
2023-01-27
First Post:
2022-08-24
Brief Title:
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Inoperable Acute Cholecystitis
Sponsor:
Fundacion Miguel Servet
Organization:
Fundacion Miguel Servet
Study Overview
Official Title:
Endosonography-guided Gallbladder Drainage vs Non-endoscopic Treatment in Patients With Inoperable Acute Cholecystitis a Multicenter Randomized Clinical Trial EUS-DRAIN
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUS-DRAIN
Brief 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 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
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 412002 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-GBDwill 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 375ºC 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 participants 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
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 412002 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-GBDwill 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 375ºC 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None