An observational study in Cholangiopancreatography, Endoscopic Retrograde, sponsored by Hospital del Rio Hortega. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Hospital del Rio Hortega · Observational
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.
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.
Pre-endoscopic management
A clinical assessment of the patient will be carried out (history, physical examination)
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.
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).
4.1 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.
Hospital del Rio Hortega is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Consecutive patients ≥ 18 years old.
Exclusion Criteria:
Refusal to sign the .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EUS-guided Entero-biliary Anastomosis
Procedure: EUS-guided Entero-biliary Anastomosis
EUS-guided Entero-biliary Anastomosis
Clinical success
Change major or equal than 2 mg/dl of total bilirrubine
Time frame: 1 year
Plan to share: No
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Hospital del Rio Hortega