The yield of staging laparoscopy will be increased by adding laparoscopic ultrasound and laparoscopic near-infrared fluorescence imaging.
ID
Bron
Aandoening
Pancreatic and periampullary cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Percentage of averted laparotomies.
Achtergrond van het onderzoek
Even after extensive preoperative assessment, up to 38% of patients undergoing laparotomy with curative intent turn out to have metastases or unresectable disease, preventing curative surgery. Moreover, a substantial number of patients present shortly after surgery with liver metastases that must have been present during surgery, but have not been identified. SL combined with LUS and NIR fluorescence imaging may identify metastases and unresectable disease, sparing patients with incurable disease the morbidity, inconvenience and expense of a futile operation. Staging laparoscopy in pancreatic cancer patients is being advocated in literature, but has not yet been implemented in clinical guidelines.This is a phase II single center, single-arm trial to assess the added value of staging laparoscopy (SL), laparoscopic ultrasonography (LUS) and near-infrared (NIR) fluorescence imaging in patients with pancreatic cancer undergoing resection with curative intent.
Doel van het onderzoek
The yield of staging laparoscopy will be increased by adding laparoscopic ultrasound and laparoscopic near-infrared fluorescence imaging.
Onderzoeksopzet
3 months follow-up
Onderzoeksproduct en/of interventie
In addition to standard-of-care, patients will receive an intravenous injection of 10 mg ICG 1-3 days prior to surgery. During surgery, patients undergo a SL, whereupon inspection, LUS and NIR fluorescence imaging will be performed. A biopsy will be taken from any suspect lesions. Decision to continue the resection is up to the surgeon. Follow-up will last at least 6 months.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 18 years or older;
- Patients with pancreatic or periampullary cancer undergoing resection with curative intent;
- Stage 2A or higher; or tumor sized 3 cm or more;
- Absence of any psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- History of allergy to iodine, shellfish or ICG;
- Pregnant or lactating woman;
- Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
Opzet
Deelname
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 | NL6461 |
NTR-old | NTR6639 |
Ander register | Commissie Medische Ethiek van het LUMC : P10.001 |