Clinical trial · Interventional
Perioperative Perfusion Measurement - a Feasibility and Usability Study
- 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 study will investigate a new method to assess tissue perfusion during surgery for esophageal cancer. When a tumor in the distal esophagus is removed, the ends of the esophagus and the stomach must be reconnected by an anastomosis. An optimal perfusion is essential to ensure a good healing of the anastomosis. If anastomotic leakage occurs, it may prolong hospital stay, increase the risk of serious complications and death, delay start-up of chemotherapy and worsen the long-term survival prognosis. During the operation the blood supply to the ends of the esophagus and stomach will be assessed in different ways; The traditional where the surgeon looks and feels on the tissue, and newer methods with an indocyanine green and cameras that illuminate the tissue with near-infrared light. The surgeon will assess whether these methods change the decision on where the ends should be sewn together.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorescence angiography | Procedure | — | UNRESOLVED |
| Q-ICG | Device | — | UNRESOLVED |
| White light perfusion assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Perfusion assessment
- description
- Q-ICG: quantitative perfusion assessment with FA White light perfusion assessment FA: fluorescence angiography without quantification
- interventionNames
- Device: Q-ICG
- Procedure: White light perfusion assessment
- Procedure: Fluorescence angiography
Primary outcomes (1)
- measure
- Completion rates
- timeFrame
- during surgery
- description
- Feasibility of perfusion assessment with traditional visual, visual FA, and Q-ICG
Secondary outcomes (2)
- measure
- Differences in resection points
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients (above 18 years) scheduled for planned open or robot-assisted resection of the gastroesophageal junction (GI junction) for GI junctional cancer. Exclusion Criteria: * Allergy towards; iodine, indocyanine green or shellfish * Liver insufficiency * Thyrotoxicosis * Pregnancy or lactation * Legally incompetent for any reason * Withdrawal of inclusion consent at any time
References
Publications (1)
- BACKGROUNDNerup N, Andersen HS, Ambrus R, Strandby RB, Svendsen MBS, Madsen MH, Svendsen LB, Achiam MP. Quantification of fluorescence angiography in a porcine model. Langenbecks Arch Surg. 2017 Jun;402(4):655-662. doi: 10.1007/s00423-016-1531-z. Epub 2016 Nov 15. PMID 27848028