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NCT04571294: PALN
Para-aortic Lymphnodes Removal During Upfront Pancreaticoduodenectomy
NA trial testing removal of para-aortic lymphnodes (PALN) in Pancreas Cancer in 180 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Humanitas Hospital, Italy |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 26 May 2020 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 May 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- removal of para-aortic lymphnodes (PALN)
Conditions studied
- Pancreas Cancer — all drugs for Pancreas Cancer →
- Pancreaticoduodenal Lymphadenopathy — all drugs for Pancreaticoduodenal Lymphadenopathy →
- Pancreas Adenocarcinoma — all drugs for Pancreas Adenocarcinoma →
Sponsor
Humanitas Hospital, Italy
Who can join
18 and older, any sex, with Pancreas Cancer or Pancreaticoduodenal Lymphadenopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Pancreaticoduodenectomy (PD) associated with lymphadenectomy is the only curative option for patients affected by pancreatic ductal adenocarcinoma (PDAC). In 2014, the International Study Group on Pancreatic Surgery (ISGPS) defined the "standard lymphadenectomy", that is mandatory during PD for PDAC. Lymphadenectomy should include the removal of the hepatoduodenal ligament nodes (stations 5, 6, 12b1, 12b2, 12c according the classification of Japanese Pancreas Society), nodes along the hepatic artery (station 8a), the posterior surface of the pancreatic head (station 13a and 13b), the superior mesenteric artery (14a right lateral side, 14b right lateral side) and nodes of the anterior surface of the pancreatic head (stations 17a and 17b). The inclusion of para-aortic lymphnodes (PALN) (station 16) in standard lymphadenectomy is still matter of debate. Moreover, some retrospectives or prospective studies reported that the presence of PALN metastases has a significant negative prognostic impact. Until now, no randomized studies comparing PD associated with standard lymphadenectomy with or without removal of PALN have been published. The aim of this study is to evaluate if the removal of station 16 should be routinely included in standard lymphadenectomy during PD for PDAC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04571294
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Humanitas Hospital, Italy trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04571294 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Humanitas Hospital, Italy
- Last refreshed: 4 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04571294.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing