No registrations found.
ID
Source
Brief title
Health condition
Pancreatic or periampullary malignancy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Investigate the effect of lymph node metastases in stations 8a, 9 and 16b1 on overall survival in patients undergoing (classical Whipple or pylorus preserving) pancreatoduodenectomy for pancreatic or peri-ampullary cancer.
Secondary outcome
To determine:
1. The prevalence of lymph node metastases in stations 8a, 9 and 16b1 in histopathologically proven pancreatic or peri-ampullary cancer.
2. In-hospital mortality / conditional survival
Background summary
Pancreatic cancer carries a poor prognosis. Even after surgical resection median survival is only 16-20 months. Improved patient selection may prevent unnecessary major surgery. Several series have advocated routine sampling of lymph nodes during exploration for pancreatoduodenectomy. It is currently uncertain whether lymph node metastases in stations 8a (common hepatic artery), 9 (celiac trunk) and/or 16b1 (aorto-caval) should lead to abandoning of pancreatoduodenectomy, especially in the era of more potent chemotherapy regimens such as FOLFIRINOX. No multicenter prospective study has routinely sampled all these stations.
Study objective
Lymph node metastases in stations 8a (common hepatic artery), 9 (celiac trunk) and/or 16b1 (aorto-caval) should lead to abandoning of pancreatoduodenectomy
Study design
2015: Start PANODE
2015-2019: Inclusion and data collection via the Dutch Pancreatic Cancer Audit
2020: End of study
Intervention
Standard resection and marking of lymph node stations 8a, 9 and 16b1 during resection of pancreatic or peri-ampullary cancer with pancreatoduodenectomy. Each center can follow routine practice and sampling.
Inclusion criteria
- Adult patients (> 18 yrs)
- Pancreatoduodenectomy (either classic Whipple or pylorus preserving) for suspected pancreatic or periampullary malignancy
Exclusion criteria
- Other active malignancy or previous history of any malignancy if not treated with curative intent >5 years previously
- Pregnancy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8424 |
| Other | METc AMC : 015.0124 |