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Laparoscopic Ischemic Conditioning Prior to Esophagectomy

NCT03896399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

PROCEDURE

Laparoscopic ischemic conditioning followed by esophagectomy

All included patients will receive a laparoscopic ischemic conditioning followed by an esophagectomy after an interval of 12-18 days.

Sponsors & Collaborators

  • University Hospital of Cologne

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Richard van Hillegersberg, MD, PhD · University Medical Center Utrecht, dept. of Surgery

  • Wolfgang Schröder, MD, PhD · University Hospital of Cologne, department of Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-11
Primary Completion
2022-05-02
Completion
2022-05-02

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896399 on ClinicalTrials.gov