Esophageal Anastomotic LeakNCT04268654
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
A study testing Preoperative Arterial Embolization in people with Esophageal Anastomotic Leak and Tissue Pressure of Oxygen, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Anastomotic Leak, Tissue Pressure of Oxygen
- What is being tested?
- Preoperative Arterial Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jun 2017to 1 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients requiring a esophagectomy with cervical esophagogastrostomy for esophageal cancer
- 18 or above years old
- Karnofsky>50%
- Acceptance and signing the full informed consent
Who cannot join
- Fistula tracheobronchial
- Metastatic disease
- Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament, atherosclerotic stenosis, etc,..)
- Severe cardiorespiratory failure
- Refuse to collaborate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.
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.
Read the detailed description
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.
- Being tested
- Preoperative Arterial Embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Arterial EmbolizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning | Experimental | 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. Receives: Procedure: Preoperative Arterial Embolization |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.
Measured: 90 days
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 90 days
Hospital Stay
investigators will consider since the day of the surgery until the day the patient will be discharged from the hospital
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start13 Jun 2017
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Anastomotic LeakStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268654
- Sponsor's protocol ID
- TIGOAL
- Status last verified
- Nov 2021
- First submitted
- 6 Feb 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer. Effects on Oxygenation and Anastomotic Leakage.
- ClinicalTrials.gov ID
- NCT04268654
- Acronym / sponsor ID
- TIGOAL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 13 Feb 2020 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning | Experimental | Procedure: Preoperative Arterial EmbolizationPreoperative 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients requiring a esophagectomy with cervical esophagogastrostomy for esophageal cancer
- 18 or above years old
- Karnofsky>50%
- Acceptance and signing the full informed consent
Key exclusion criteria (5 listed)
- Fistula tracheobronchial
- Metastatic disease
- Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament, atherosclerotic stenosis, etc,..)
- Severe cardiorespiratory failure
- Refuse to collaborate in the study
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 |
|---|---|---|
| Preoperative Arterial EmbolizationPAE 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. | Procedure or surgery | Ischemic Conditioning |
Primary outcome
Anastomotic leakage
Time frame: 90 days
Clinic, endoscopy or computed tomography with oral contrast of dehiscence of oesophagogastric anastomosis.
6 secondary outcomes
Tissue pressure oxygen (Ptio2)
Time frame: 48 hours
Relation between PtiO2 and anastomotic leakage
Time frame: 90 days
Gastric Conduit ischemia
Time frame: 90 days
Morbidity
Time frame: 90 days
Mortality
Time frame: 90 days
Hospital Stay
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Arterial Embolization in people with Esophageal Anastomotic Leak and Tissue Pressure of Oxygen, run by Fundación para la Investigación del Hospital Clínico de Valencia 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 5 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: finished, as of the sponsor's last update on 21 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic leakage (time frame: 90 days). 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 21 Jan 2022.