Multimodality Preoperative Evaluation of lymph nodes of perihilar cholangiocarcinoma - a pilot study

Multimodality Preoperative Evaluation of lymph nodes of perihilar cholangiocarcinoma - a pilot study - POELH

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49893

Enrollment

Registered

2021-10-19

Start date

2021-11-17

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extrahepatic bile duct cancer Perihilar cholangiocarcinoma

Interventions

In each patient with suspected resectable pCCA a systematic survey of regional and non-regional lymph nodes will be performed on cross sectional imaging, on EUS (with FNA or FNB of suspicious lymph

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Presumed resectable pCCA. - Written informed consent must be given according to ICH/GCP, and national/local regulations. - Age > 18 years.

Exclusion criteria

Exclusion criteria: - Patients with a history of treated pCCA - Patients with a history of treated liver malignancy - Patients with a contra-indication for EUS + FNA/FNB (f.e. uncorrectable coagulopathy or platelet disorder), in line with current clinical practice

Design outcomes

Primary

Measure	Time frame
- To evaluate the feasibility of systematic survey of regional and non-regional lymph nodes by EUS-FNA/FNB, defined as: o Number of patients in which all potential lymph node locations were successfully surveyed and FNA/FNB is possible when indicated.	—

Secondary

Measure	Time frame
- To correlate regional and non-regional lymph nodes identified by EUS to cross-sectional imaging and surgery, defined as: o Number of lymph nodes correctly identified as malignant based on visualization and biopsy in comparison to cross-sectional imaging and surgery - To evaluate the different locations of positive lymph nodes and its effect on survival, defined as: o Days of survival after EUS and surgery per N0, N1, N2 or M status. - To identify short term and long term complications of EUS-FNA/FNB in detecting lymph nodes in patients with pCCA, defined as: o Short term (3g/dl with the need for resuscitation or additional intervention * Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery * Mortality o Long term (>30 days) * Tumor seeding; defined as proof of carcinoma in the biopsy tract during follow-up or at autopsy	—

Measure

Time frame

- To correlate regional and non-regional lymph nodes identified by EUS to cross-sectional imaging and surgery, defined as: o Number of lymph nodes correctly identified as malignant based on visualization and biopsy in comparison to cross-sectional imaging and surgery - To evaluate the different locations of positive lymph nodes and its effect on survival, defined as: o Days of survival after EUS and surgery per N0, N1, N2 or M status. - To identify short term and long term complications of EUS-FNA/FNB in detecting lymph nodes in patients with pCCA, defined as: o Short term (3g/dl with the need for resuscitation or additional intervention * Perforation: defined as evidence of air or luminal contents outside the gastro-intestinal tract together with clinical symptoms, requiring percutaneous drainage or surgery * Mortality o Long term (>30 days) * Tumor seeding; defined as proof of carcinoma in the biopsy tract during follow-up or at autopsy

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)