Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05246657 |
| Other study ID # |
ATENHEA |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
July 1, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Hospital del Río Hortega |
| Contact |
Carlos Maroto Martín, PI |
| Phone |
983420400 |
| Email |
cmarotom[@]saludcastillayleon.es |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background: Transpapillary EUS-BD (rendezvous/antegrade) is gaining acceptance in BBO. The
potential of transmural EUS-BD (hepaticogastrostomy/choledochoduodenostomy) in complex BBO
warrants study.
Aims: To assess feasibility and efficacy of TEA using transmural covered self-expandable
metal-stents (cSEMS) to provide interval biliary drainage and create TAF for biliary
endotherapy under cholangioscopy or fluoroscopy in BBO not amenable to ERCP.
Description:
3.1 Design
Prospective multicenter case series
3.1 Design
Prospective multicenter case series
3.2 Study population
The study population includes patients with benign biliary obstruction in whom a temporary
enterobiliary anastomosis is considered by transmural stent deployment. All consecutive
patients who meet inclusion criteria and do not present exclusion criteria identified in the
endoscopy units of the Río Hortega University Hospital in Valladolid will be invited to
participate.
3.4. Intervention
Patients who meet the inclusion criteria and do not present any exclusion criteria
(preendoscopic) will be invited to participate in the study. 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 treatment.
1. Pre-endoscopic management
A clinical assessment of the patient will be carried out (history, physical examination)
2. Endoscopic procedure:
All patients will receive antibiotic prophylaxis before the procedure according to the
currentguidelines. Endoscopic interventions will be performed under sedation by expert
endoscopists in tertiary centers with or without the participation of residents.
-The EUS-guided enterobiliary anastomosis technique is performed as follows: a standard
therapeutic channel echoendoscope (GF-UCT 180; Olympus Europa) is inserted into the
stomach or jejunum to allow endosonographic view of left liver lobe. Intrahepatic ducts
of adequate caliber are identified avoiding the intervening vessels identified by
Doppler. In the case of EUS-guided choledocochoduodenostomy (EUS-CD), the echoendoscope
is passed into the duodenum to visualize the common bile duct and its proper caliber. A
19-gauge needle (Expect; Boston Scientific, Marlborough, Mass) preloaded with
water-soluble contrast material is used to puncture in the selected duct through the
liver, and entry is confirmed by injection of contrast. The needle is cleaned with
saline and a 0.025-inch, 450-cm-long hydrophilic-tipped guidewire (VisiGlide; Olympus
Spain) is passed antegrade toward the biliary tree. The needle is withdrawn and, in case
of intrahepatic puncture, the tract is ballon-dilated(CRE controlled radial expansion
balloon dilator; Boston Scientific) directly over the guide wire. Balloon dilation
begins from within the left intrahepatic duct and continues sequentially to the tip of
the endoscope and through the gastric or intestinal wall. the tract was dilated with a
biliary dilation balloon (CRE controlled radial expansion balloon dilator; Boston
Scientific ) directly over the guide wire. Sequential balloon dilation fromthe left
intrahepatic duct into the tip of the endoscope,is performed through the gastric or
intestinal wall. the tract was dilated with a biliary dilation balloon (CRE controlled
radial expansion balloon dilator; Boston Scientific) directly over the guide wire.
Balloon dilatation begins from within the left intrahepatic duct and continues
sequentially to the tip of the endoscope and through the gastric or intestinal wall.
Subsequently, a stent is deployed under radiological and endoscopic ultrasound view, ,
creating the enterobiliary anastomosis. The type and size of the stent, as well as the
option of using anchoring methods or not, will be chosen at the discretion of the
endoscopist and will be collected in the database.
- After performing the anastomosis, one or more therapeutic sessions will be carried
out through the stent or, removing it, through the bare fistula. The first of these
sessions can be carried out on the same day as the fistula or on a deferred basis.
The techniques carried out on each of the sessions will depend on the initial
indication.
- Once the useful life of the enterobiliary fistula has ended, that is, when the
endoscopist decides that the therapeutic sessions have ended, either by achieving
clinical success or by opting for surgical or percutaneous rescue, the stentwill be
removed endoscopically, registering in the CRD the technique used for it.
3. Follow-up:
It will be carried out through contact with your doctors/responsible nursing staff after 24
hours, and through in-personor telephone visits depending on availability and the patient's
clinical situation 7 days after performing the enterobiliary fistula, 24 hours after each one
of the endoscopic sessions and at 24h, 30 days and at 3 and 6 months (+/- 5 days) after
removal of the stent Esta parte no la entiendo muy bien.
During the visits, the clinical situation, blood tests with complete blood count and liver
function parameters and possible unidentified complications will be collected. The visit at
24 hours is part of normal clinical practice, since the patient is usually kept under
observation until the day after the procedure, to confirm the absence of immediate
complications.
3.5 Sample size
The studies available on this type of procedure have a small number of cases, given that they
are highly specialized techniques, which are performed only in reference hospitals by expert
personnel. We do not have studies that evaluate the variability between operators in this
type of procedure, therefore it is difficult to estimate a minimum sample size. Taking into
account the number of procedures performed in the participating centers, our goal is to
include a minimum of 50 procedures.
3.6 Data collection
All the variables concerning the characteristics of the procedure, type of stent and the
complications that occurred will be collected in each center. The variables concerning
follow-up will be collected centrally, through in-personor telephone visits with the
responsible physicians, which will be carried out 24 hours after each endoscopic session, and
through face-to-face or telephone visits depending on availability and the clonic ??
situation of the patient. patient 7 days after making the fistula and 30 days and 3 and 6
months after removal of the prosthesis.
3.7 Data handling
The CRF data will be entered by the principal investigator or collaborating investigators
anonymously, encrypted and dissociated from the clinical information by means of a patient
identification code (ID), in an online database. The responsible physician, who is also a
researcher, will define an ID for each patient, whose relationship with the clinical history
will only be accessible by him, with its custody in a file protected by a personal password.
The data entered in the database will be anonymous and the database will be protected with a
password to which only researchers will have access.
With regard to the application of the Organic Law on Data Protection 15/1999 and Royal Decree
1720/2007 that develops it, it should be noted that the protocol defined in the project aimed
at epidemiological analysis determines that the files will record information completely
anonymized. A file will be kept with the information compiled for the development of the
project within the framework defined in the Security Document of the maximum level of the Río
Hortega University Hospital, whose responsibility is the Management of this organization.
this document is public, of obligatory knowledge and available on the Intranet of the Río
Hortega University Hospital. The levels of security, access and availability will be those
defined in this document.
3.8 Statistical analysis
Categorical variables will be described as percentages. Continuous with normal distribution
as mean and standard deviation. Continuous variables with non-normal distributions will be
described as medians and interquartile range (the range may also be offered). The analysis
will be performed using Stata (StataCorp. 2016. College Station, Texas).
4. ETHICAL ASPECTS
4.1 Benefit-risk assessment for research subjects
The benefit we seek is to assess the efficacy and safety profile of enterobiliary anastomosis
as a therapeutic access fistula in benign biliary obstructions. We consider that
participating in the study does not imply a significant increase in the usual risks in these
patients, given that it is a purely observational project. Performing an endoscopic
ultrasound-guided bilioenteroanastomosis presents risks similar to those assumed during any
advanced therapeutic endoscopy (perforation, gastrointestinal bleeding, migration of the
stent).
As technical aspects of the study, the stents are those usually used for the creation of this
type of anastomosis, being an indication included in the current technical data sheet of the
product.
4.2. Data Confidentiality
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 encrypted with the participant's ID, to
maintain their anonymity. The database will be password protected and only accessible by
researchers. During the study, strict compliance with Law 3/2018 on the Protection of
Personal Data is guaranteed.
