The new treatment algorithm for patients with high-risk T1b EAC consisting of radical ER of the tumor, followed by a sentinel node procedure with selective lymphadenectomy is feasible and safe.
Bron
Verkorte titel
Aandoening
High-risk T1b esophageal adenocarcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
- Surgical morbidity, defined as any clinically relevant adverse which is related to sentinel node navigation surgery.
- Esophageal and gastric functioning.
Achtergrond van het onderzoek
High-risk T1b esophageal adenocarcinoma (EAC) is currently treated with esophagectomy with lymph node dissection given the high rates of lymph node metastases (16-41%). However, recent studies reporting on patients after endoscopic resection (ER) of T1b EAC suggest a much lower risk of lymph node metastasis. Esophagectomy is associated with substantial morbidity (up to 45%) and mortality (2-4%). Recently, our study group stepwise investigated a treatment strategy comprising a sentinel node procedure to identify patients with low risk of lymph node metastasis to spare these patients an unnecessary esophagectomy. The objective of this study is to evaluate the feasibility and safety of a new treatment algorithm for patients with high-risk T1b EAC consisting of radical ER of the tumor, followed by a sentinel node navigation surgery procedure with selective lymphadenectomy.
Doel van het onderzoek
The new treatment algorithm for patients with high-risk T1b EAC consisting of radical ER of the tumor, followed by a sentinel node procedure with selective lymphadenectomy is feasible and safe.
Onderzoeksopzet
Follow-up of 24 months.
Onderzoeksproduct en/of interventie
Sentinel node procedure using a radioactive tracer and lymphoscintigraphy in combination with indocyanine green (ICG) and near-infrared (NIR) technology.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1) High-risk submucosal EAC on histology (diagnosed in ER specimen) confirmed by an expert gastrointestinal pathologist, defined as:
a) Infiltration of EAC into the deep submucosa (>500 µm), and/or;
b) Poor differentiation (G3) or undifferentiated (G4) EAC, and/or;
c) Presence of lymphovascular invasion
2) Tumor-free deep vertical resection margins in the ER specimen
3) Clinically staged as T1N0M0
4) Fit for endoscopy and surgery per institution’s standards
5) Older than 18 years of age at time of informed consent
6) Willing and able to comply with follow-up requirements
7) Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1) History of esophageal squamous cell carcinoma
2) Clinically staged as N+
3) Prior neoadjuvant chemoradiation therapy
4) Prior esophageal surgery interfering with the procedure
5) Other primary tumor with a life-expectancy less than 3 years
6) Known allergy for the radioactive tracer (technetium) or dye (indocyanine green)
7) Severe medical comorbidities precluding endoscopy and/or surgery
8) Pregnant or planning to become pregnant during period of study
9) Refusing or unable to provide written informed consent
10) Participation in another study within the 30 days preceding or during the present study, interfering with participation in the current study
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8100 |
Ander register | METC Utrecht : METC 19-696 |
CCMO | NL71361.041.19 |