Laparoscopic Ischemic Conditioning Prior to Esophagectomy

NCT03896399 | Completed

• 1 other identifier: NL67819.041.18
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 2

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 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

Keywords

Esophageal Cancer; Esophagectomy; Ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• Number of participants with a grade 2 or higher complication after laparoscopic ischemic conditioning

  Complications grade 2 and higher (Clavien-Dindo classification)

  Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days.

Secondary Outcomes (10)

• Number of participants with a grade 1 complication after operation 1 (laparoscopic ISCON)

  Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days.

• Duration of operation 1 (laparoscopic ISCON)

  During operation 1

• Bloodloss during operation 1 (laparoscopic ISCON)

  During operation 1

• Day of discharge after operation 1 (laparoscopic ISCON)

  After operation 1, usually on the third post-operative day

• Number of participants with anastomotic leakage after operation 2 (esophagectomy)

  Within 30 days after operation 2

Study Arms (1)

Laparoscopic ischemic conditioning followed by esophagectomy

EXPERIMENTAL

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

Procedure: Laparoscopic ischemic conditioning followed by esophagectomy

Interventions

Laparoscopic ischemic conditioning followed by esophagectomy PROCEDURE

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

Laparoscopic ischemic conditioning followed by esophagectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven adenocarcinoma (AC) or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ)
• Planned to undergo transthoracic esophagectomy or transhiatal esophagectomy
• Preoperative computed tomography (CT)
• Vascular arterial changes: "major calcifications" of the thoracic aorta according to the "Uniform calcification score" (UCS) and or a 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

You may not qualify if:

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

Sponsors & Collaborators

• UMC Utrecht: lead
• University Hospital of Cologne: collaborator

Study Sites (2)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• Veen AV, Schiffmann LM, de Groot EM, Bartella I, de Jong PA, Borggreve AS, Brosens LAA, Santos DPD, Fuchs H, Ruurda JP, Bruns CJ, van Hillegersberg R, Schroder W. The ISCON-trial protocol: laparoscopic ischemic conditioning prior to esophagectomy in patients with esophageal cancer and arterial calcifications. BMC Cancer. 2022 Feb 5;22(1):144. doi: 10.1186/s12885-022-09231-x.

  PMID: 35123419 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, surgeon

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 1, 2019
• Study Start: November 11, 2019
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: February 19, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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

Locations

NL (1); DE (1)