Clinical trial · Interventional
Laparoscopic Ischemic Conditioning Prior to Esophagectomy
Laparoscopic Ischemic Conditioning Prior to Esophagectomy in Patients With Esophageal Cancer and Arterial Calcifications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic ischemic conditioning followed by esophagectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Laparoscopic ischemic conditioning followed by esophagectomy
- description
- All included patients will receive a laparoscopic ischemic conditioning followed by an esophagectomy after an interval of 12-18 days.
- interventionNames
- Procedure: Laparoscopic ischemic conditioning followed by esophagectomy
Primary outcomes (1)
- measure
- Number of participants with a grade 2 or higher complication after laparoscopic ischemic conditioning
- timeFrame
- Occuring after operation 1(laparosocpic ISCON), but before operation 2 (esophagectomy). This time-frame is usually 13-15 days.
- description
- Complications grade 2 and higher (Clavien-Dindo classification)
Secondary outcomes (10)
- measure
- Number of participants with a grade 1 complication after operation 1 (laparoscopic ISCON)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * 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 Exclusion criteria: * Not able to undergo study treatment. * Metastatic disease (M1)
References
Publications (1)
- DERIVEDVeen 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