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Laparoscopic Ischemic Conditioning Prior to Esophagectomy (ISCON)

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ClinicalTrials.gov Identifier: NCT03896399
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
University Hospital of Cologne
Information provided by (Responsible Party):
Richard van Hillegersberg, UMC Utrecht

Brief 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 13-15 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Laparoscopic ischemic conditioning followed by esophagectomy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Ischemic Conditioning Prior to Transthoracic Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Laparoscopic ischemic conditioning followed by esophagectomy
All included patients will receive a laparoscopic ischemic conditioning followed by an Ivor-Lewis esophagectomy after an interval of 13-15 days.
Procedure: Laparoscopic ischemic conditioning followed by esophagectomy
All included patients will receive a laparoscopic ischemic conditioning followed by an Ivor-Lewis esophagectomy after an interval of 13-15 days.




Primary Outcome Measures :
  1. Number of participants with a grade 2 or higher complication after laparoscopic ischemic conditioning [ Time Frame: Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days. ]
    Complications grade 2 and higher (Clavien-Dindo classification)


Secondary Outcome Measures :
  1. Number of participants with a grade 1 complication after operation 1 (laparoscopic ISCON) [ Time Frame: Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days. ]
    Grade 1 complications after operation 1 (laparoscopic ISCON)

  2. Duration of operation 1 (laparoscopic ISCON) [ Time Frame: During operation 1 ]
    Duration of operation 1 (laparoscopic ISCON)

  3. Bloodloss during operation 1 (laparoscopic ISCON) [ Time Frame: During operation 1 ]
    Bloodloss during operation 1 (laparoscopic ISCON)

  4. Day of discharge after operation 1 (laparoscopic ISCON) [ Time Frame: After operation 1, usually on the third post-operative day ]
    Day of discharge after operation 1 (laparoscopic ISCON)

  5. Number of participants with anastomotic leakage after operation 2 (esophagectomy) [ Time Frame: Within 30 days after operation 2 ]
    Anastomotic leakage after operation 2 (esophagectomy)

  6. Number of participants with grade 3b or higher complications after operation 2 (esophagectomy) [ Time Frame: Within 30 days after operation 2 ]
    Grade 3b (Clavien-Dindo classification) or higher complications after operation 2 (esophagectomy)

  7. Number of participants with 30 day mortality after operation 2 (esophagectomy) [ Time Frame: Within 30 days after operation 2 ]
    30 day mortality after operation 2 (esophagectomy)

  8. Induction of angiogenesis in tissue [ Time Frame: Biopsies are taken at the start, or within 24 hours of operation 1 and operation 2. In addition, the anastomoc donut or tip of gastric tube is collected during operation 2 (esophagectomy) after formation of the anastomosis. ]
    Paraffin embedded sections (10µm) will be stained by immunohistochemistry against CD31 (vessel density) or smooth-muscle-actin positive pericytes to characterize vascularity

  9. Induction of angiogenesis by biomarkers of microcirculation [ Time Frame: Peripheral blood is taken at the start, or within 24 hours of operation 1 ]
    A cytokine profile will be measured in the peripheral blood, consisting of VEGF, IL-8, IL-6, TNF-alpha and Ang-2

  10. Redistribution of blood flow by measurement of indocyanine green (ICG) fluorescence angiography [ Time Frame: During operation 1 and during operation 2 (esophagectomy) ]
    Redistribution of blood flow by measurement of indocyanine green (ICG)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Histologically proven adenocarcinoma (AC) or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ)
  • Planned to undergo Ivor-Lewis transthoracic esophagectomy
  • Preoperative computed tomography (CT)
  • Vascular arterial changes: "major calcifications" of the thoracic aorta according to the "Uniform calcification score" (UCS) and any additional calcification or stenosis of the celiac axis according to the "modified NASCET score". (Appendix 1 and 2) (7,17)
  • ASA I-III
  • European Clinical Oncology Group (ECOG) performance status of 0,1 or 2
  • Age > 17
  • Written informed consent

Exclusion criteria:

  • Not able to undergo study treatment.
  • Metastatic disease (M1)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896399


Contacts
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Contact: Arjen van der Veen, MD +31 (0)88-755 8507 a.vanderveen-12@umcutrecht.nl
Contact: Isabel Bartella, MD, PhD +492214784803 isabel.bartella@uk-koeln.de

Locations
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Germany
University Hospital of Cologne Recruiting
Cologne, North Rhine-Westphalia, Germany, 50937
Contact: Isabel Bartella, MD, PhD    +49 (0)221-478 4803    isabel.bartella@uk-koeln.de   
Contact: Wolfgang Schröder, MD, PhD    +49 (0)221-478 4803    wolfgang.schroeder@uni-koeln.de   
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Arjen van der Veen, MD    +31 (0)88-755 8507    a.vanderveen-12@umcutrecht.nl   
Contact: Richard van Hillegersberg, MD, PhD    +31 (0)88-755 8074    r.vanhillegersberg@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
University Hospital of Cologne
Investigators
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Principal Investigator: Richard van Hillegersberg, MD, PhD University Medical Center Utrecht, dept. of Surgery
Principal Investigator: Wolfgang Schröder, MD, PhD University Hospital of Cologne, department of Surgery

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Responsible Party: Richard van Hillegersberg, Professor, surgeon, UMC Utrecht
ClinicalTrials.gov Identifier: NCT03896399     History of Changes
Other Study ID Numbers: NL67819.041.18
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: This will be published
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The protocol will be published in an international journal after the start of the study
Access Criteria: The protocol will be accessibel from the journal in which it will be published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard van Hillegersberg, UMC Utrecht:
Esophageal Cancer
Esophagectomy
Ischemic conditioning
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases