An interventional study of Preoperative Arterial Embolization in Esophageal Anastomotic Leak and Tissue Pressure of Oxygen, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-21.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Prevention
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Among 17 studies in Anastomotic Leak with a site in Spain — 3 open to participants now, 5 under way, none of them phase 3. Anastomotic Leak · Spain.
Among the 17 studies in Anastomotic Leak with a site in Spain, this one is one of 3 that started in 2017, is one of 6 with no phase, and was the 6th registered.
240 studies on the registry are indexed under Anastomotic Leak; 72 are open to participants now.
Browse Anastomotic Leak studies →3 of the 17 studies in Anastomotic Leak with a site in Spain are open now. Recruiting first, the newest first:
Amsterdam UMC, location VUmc · Sites in Spain, France, Italy and 2 more countries
Ages 18+
Hospital San Carlos, Madrid · Sites in Spain
Ages 18–99
Bordeaux Colorectal Institute · Sites in Spain, Belgium, Canada and 3 more countries
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 45 Anastomotic Leak studies recruiting now, 23 (51%) set no upper age limit and 11 (24%) stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 3 started in 2017.
This study's enrollment of 40 is below the median of 140 across 128 interventional studies indexed under Anastomotic Leak.
Median enrollment 145 across the 8 interventional studies, 400 across the 9 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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2 of 17 have an industry lead sponsor. The 10 most frequent:
Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 73 studies on the registry; 18 are open to participants now.
Fundación para la Investigación del Hospital Clínico de Valencia has 1 study filed under Anastomotic Leak — fewer than ten, so there is no comparison to draw.
1 of the studies in Anastomotic Leak with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06097078Aesculap AGEndoluminal Vacuum Therapy to Prevent Anastomotic Leakage After Esophagectomy Due to Esophageal Cancer | 2026-11 |
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Among the 17 studies in Anastomotic Leak with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is a randomized clinical trial to clarify if preoperative embolization of gastric arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for esophageal cancer comparing an experimental group vs control group.
In patients with infracarinal esophageal carcinoma, the surgery is a complex procedure and with a high morbidity. It consists of a subtotal esophagectomy with tubular gastroplasty and cervical esophagogastric anastomosis. The most important complication is the anastomotic leakage with a high mortality. Among the possible causes of anastomotic leakage an important factor is the impaired microcirculation in the anastomotic region after the partial devascularization of the stomach during the surgery. There are several experimental studies about the different techniques to improve this vascularization and their effects on mucosal oxygenation. There are several methods currently used for assessing tissue oxygenation. The polarographic partial pressure of oxygen (pO2) electrode has been considered as the 'gold standard' for measuring oxygen tension. This is the reason why tissue pressure of oxygen (PtiO2) will be measured by Licox® (Integra Neuroscience) system in two groups. There aren't prospective randomized controlled trials to answer these questions. For this reason the investigators propose to perform a prospective randomized controlled trial in patients underwent on this surgery, comparing two groups: one of them will be carried out a preoperative arterial embolization (PAE), and the other one will be operated directly, to demonstrate if the ischemic conditioning by PAE can reduce the incidence of anastomotic esophagogastric leakage and improve the gastric conduit oxygenation.
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.
Exclusion Criteria:
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.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative artery embolization prior to esophagectomy Tissue pressure of oxygen measurement in both arms by Licox system. The probe is inserted directly through the skin as a cervical drainage and it is fixed by Witzel technique in the gastric conduit. It is removed after the three measurements (intraoperatively, 24h and 48h after surgery) of the PtiO2 as a normal drainage.
Procedure: Preoperative Arterial Embolization
Surgery without previous ischemic conditioning of the gastric conduit Tissue pressure of oxygen measurement in both arms by Licox system. The probe is inserted directly through the skin as a cervical drainage and it is fixed by Witzel technique in the gastric conduit. It is removed after the three measurements (intraoperatively, 24h and 48h after surgery) of the PtiO2 as a normal drainage.
PAE will be performed by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery. An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. Embolization by coils of the left gastric artery, splenic artery and the right gastric artery is realized.
Anastomotic leakage
Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.
Time frame: 90 days
Tissue pressure oxygen (Ptio2)
Licox oxygen monitoring system placed during the surgery in the gastric conduit. Measurements: intraoperatively and 24 hours and 48 hours after surgery.
Time frame: 48 hours
Relation between PtiO2 and anastomotic leakage
We will analyse the correlation between the measurement of tissue pressure oxygen and the prevention of anastomotic leakage.
Time frame: 90 days
Gastric Conduit ischemia
Plasty ischemia when one or more of the following criteria is present: * Endoscopic evidence of gastric mucosa ischemia * Evidence in a thoracoabdominal CT with endovenous contrast
Time frame: 90 days
Morbidity
Investigator will analyse the morbidity between the two groups with the common postoperative complications: - Anastomotic leakage * Wound infection * Pulmonary complications * Complications related to PAE * Cardiologic complications
Time frame: 90 days
Mortality
Postoperative mortality has been defined as any death, regardless of cause, occurring within 30 days after surgery in or out of the hospital.
Time frame: 90 days
Hospital Stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Time frame: 90 days
Ran from Jun 2017 to primary completion in Dec 2021, 53 months.
Of 58 non-industry interventional studies with no phase under Anastomotic Leak, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 42. This study's 53 months is above that.
Counting every sponsor, half of 65 studies reached it within 32 months; a quarter within 19 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Fundación para la Investigación del Hospital Clínico de Valencia