The ARTERY FIRST Approach for Resection of Pancreatic Head Cancer (Artery first)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a prospective non-randomized trial with two study groups. The trial is designed to show if the ARTERY FIRST approach reduces the rate of R1 resections in patients undergoing surgery for cancer of the pancreatic head.
After the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. Informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.
Studietype
Registrering (Forventet)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Tyskland, 69120
- Rekruttering
- Department of General, Visceral and Transplantation Surgery, University of Heidelberg
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Ta kontakt med:
- Rahbari
- E-post: nuh.rahbari@med.uni-heidelberg.de
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation)
- Patients scheduled for curative resection
- No evidence of distant metastases
- Age equal or greater than 18 years
- Informed consent
Exclusion Criteria:
- Expected lack of compliance
- Impaired mental state or language problems
- patient having had neoadjuvant radiochemotherapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Artery first group
The basic principle of the "artery first" approach is the early identification of the SMA at its origin at the aorta with the further resection then being guided by its anatomic course. The dissection is carried cephalad along the aorta until the origin of the SMA is reached. The posterior and right aspect of the SMA is then dissected over a few centimeters. On the right side of the SMA a replaced or accessory right hepatic artery, if present, will be identified and preserved. This maneuver should be done, if infiltration of the SMA is suspected as the procedure can be terminated at this point. Once the situation at the SMA is assessed and resectability is confirmed resection will be done. |
early identification of SMA to evaluate infiltration
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Aktiv komparator: Conventional Group
A wide Kocher manoeuver is performed to fully mobilize the duodenum and the head of the pancreas.
The colonic mesentery on the right side is separated from the anterior surface of the duodenum and the head of the pancreas.
The size of the tumor and its relation to the superior mesenteric artery, the celiac trunk, the mesentery, the portal vein, and the superior mesenteric vein is assessed.
If resectability is given a Kausch-Whipple's resection is performed.
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conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of R1 resections
Tidsramme: up to 1.5 years
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positive resection margins as described by the pathologists of the University of Heidelberg
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up to 1.5 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Exploratory analyses
Tidsramme: up to 1.5 years
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Exploratory analyses of frequencies of complications and serious adverse events
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up to 1.5 years
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NNR-7
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