Esophageal Anastomotic Leak Clinical Trial
Official title:
Prospective Randomized Clinical Trial on Delay Phenomenon Utility in Preventing Oesophagogastric Anastomotic Dehiscence After Ivor-Lewis Esophagectomy. Pilot Study.
This is a randomized clinical trial to clarify if the delay phenomenon could reduce the incidence of oesophagogastric dehiscence after an esophagectomy for esophageal cancer comparing an experimental group vs control group. The delay phenomenon will be performed by an arteriographic approach.
Subtotal esophagectomy with tubular gastroplasty to upper mediastinum and esophagogastric
anastomosis (Ivor-Lewis procedure) is a very complex surgical technique. It is performed in
patients with infracarinal esophageal carcinoma and is associated with a high morbidity rate
in specialized centers (up to 60% in some groups). One of the most important postoperative
complications is the oesophagogastric anastomotic leakage which leads to high morbidity
(mediastinitis, respiratory failure, pleural effusion) and mortality rate (up to 60%
depending on the reports).
The most important cause of anastomotic leakage is the stomach's extreme sensitivity to
ischemic injury. There are several experimental studies that have demonstrated that the delay
phenomenon before the esophageal resection surgery aims to improve blood perfusion after a
period of time. Few studies, only case-reports, describe a decrease in the incidence of
intrathoracic and cervical anastomotic leakage. May the delay phenomenon reduce the incidence
of anastomotic intrathoracic leakage?. There aren't any prospective randomized controlled
trials to answer this question.
For this reason the investigators propose to perform a prospective randomized controlled
trial in patients who underwent a subtotal esophagectomy (Ivor-Lewis procedure), comparing
two groups: one of them will be submitted to a delay phenomenon by arteriographic procedure
before esophageal resection surgery, and the other one will be operated on directly, to
demonstrate if the delay phenomenon can reduce the incidence of anastomotic esophagogastric
leakage.
We decided to conduct this trial as a pilot study due to the fact that the number of patients
needed to achieve statistical significance was to high and would have taken almost 10 years.
We established a recruitment period of 3 years, in wich we intend to include 60 patients.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04268654 -
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.
|
N/A | |
| Active, not recruiting |
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|
Phase 3 |