Assess the safety and feasibility of laparoscopic ISCON 12-18 days prior to esophagectomy for esophageal cancer in patients with arterial calcifications.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
all complications grade 2 and higher (Clavien-Dindo classification) occurring
during or after operation 1 (laparoscopic ISCON) and before operation 2
(esophagectomy).
Secondary outcome
secondary outcomes with regard to operation 1 (laparoscopic ISCON) are the
duration of the procedure, blood loss, day of discharge postoperatively and
grade 1 complications. Secondary outcomes with regard to operation 2
(esophagectomy) are anastomotic leakage rate, all other grade *3b complications
and 30 day mortality. Further secondary endpoints are the induction of
angiogenesis by biomarkers of microcirculation and redistribution of blood flow
by measurement of indocyanine green (ICG) fluorescence angiography.
Background summary
Anastomotic leakage is the most important surgical complication following
esophagectomy for esophageal cancer, leading to increased morbidity and
mortality. A major cause of leakage is impaired healing due to ischemia of the
gastric tube that is used for reconstruction of the gastrointestinal tract.
Calcifications of the aorta or stenosis of the celiac trunk on pre-operative CT
scan have been shown to be associated with an increased risk of anastomotic
leakage. So far, no individualized treatment has been initiated for this
selected group of patients. Laparoscopic ischemic conditioning (ISCON) of the
gastric tube aims to increase perfusion at the anastomotic site by
redistribution of the gastric blood flow and/or induction of angiogenesis. This
is achieved by occlusion of the supplying gastric arteries except for the right
gastroepiploic artery during a separate intervention prior to esophagectomy. Of
note, these arteries would also be occluded during conventional esophagectomy,
but with laparoscopic ISCON they are occluded at an earlier moment in time
during a separate intervention. Retrospective studies have demonstrated the
safety of this technique. Prospective studies have not yet been performed.
Study objective
Assess the safety and feasibility of laparoscopic ISCON 12-18 days prior to
esophagectomy for esophageal cancer in patients with arterial calcifications.
Study design
Two center phase II prospective single-arm safety and feasibility trial.
Intervention
Laparoscopic ISCON followed by esophagectomy after an interval of 12-18 days.
Study burden and risks
the additional burden for the patient consists of an extra operation of
approximately 40 minutes during which laparoscopic ISCON will be performed,
prior to the planned esophagectomy. We would classify the current study as
medium risk. Potential benefits in comparison to current standard treatment are
a reduced risk of anastomotic leakage and severity of anastomotic leakage.
Potential risks are complications following operation 1 (laparoscopic ISCON).
Mainly, based upon prior experience, we expect gastroparesis to occur in 25% of
patients. Patients with gastroparesis have an increased risk of aspiration and
will require a stomach emptying by nasogastric tube and nasojejunal tube
feeding till the performance of operating 2 (esophagectomy).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with *major
calcifications* of the thoracic aorta (UCS) or stenosis of the celiac axis
(modified NASCET score) on preoperative CT scan, who are planned to undergo
transthoracic of transhiatal esophagectomy.
Exclusion criteria
Not able to undergo study treatment (surgery).
Metastatic disease (M1)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67819.041.18 |