Laparoscopic Ischemic Conditioning Prior to Esophagectomy — ISCON  

Esophageal Cancer Clinical Trial

Official title: Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications

Status Recruiting

Clinical Trial Summary

This is a two center phase II prospective single-arm safety and feasibility trial for 20 patients with resectable esophageal carcinoma with an increased risk for anastomotic leakage, as based upon UCS and NASCET calcification scores on pre-op CT-scan. In these patients, laparoscopic ischemic conditioning is performed 12-18 days before an Ivor-Lewis esophagectomy. The primary outcome is all complications grade 2 and higher (Clavien-Dindo classification) occurring during or after the laparoscopic ischemic conditioning. Secondary outcomes are complications after the esophagectomy, and the induction of angiogenesis by biomarkers of microcirculation and redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography.

Clinical Trial Description

Rationale:

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.

Primary 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.

Study population:

Patients with resectable esophageal carcinoma (cT1-4a, N0-3, M0) with "major calcifications" of the thoracic aorta (UCS) and any additional calcification or stenosis of the celiac axis (modified NASCET score) on preoperative CT scan, who are planned to undergo esophagectomy.

Intervention:

Laparoscopic ISCON followed by esophagectomy after an interval of 12-18 days.

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 outcomes:

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 or higher 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.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

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). ;

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

• NCT number: NCT03896399
• Study type: Interventional
• Source: UMC Utrecht
• Contact: Eline De Groot, MD
• Phone: +316 49391569
• Email: e.m.degroot-26@umcutrecht.nl
• Status: Recruiting
• Phase: N/A
• Start date: April 9, 2019
• Completion date: December 2022