Detection of Upper Gastrointestinal Tumour Depth and Demarcation Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Recruiting
Phase 1
Phase 2
Interventional Study
Esophageal Carcinoma
Gastric Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 10 (estimated)
- Sponsor
- University Medical Center Groningen · Other
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About This Trial
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients with confirmed superficial esophageal and/or gastric adenocarcinoma (T1) and are scheduled for ESD within the UMCG;
* Age of 18 years or older;
* Able to provide written informed consent.
Exclusion Criteria (contraindications for indocyanine green):
* Known allergy …
Contacts