Dissecting the Pattern of Nodal Spread in Post-neoadjuvant Pancreatoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

850 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

There has been long-standing debate about nodal dissection in pancreatoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC), with most studies examining the value of nodal yields, number of metastatic nodes and spatial location of metastases being conducted in the upfront surgery setting. With increasing use of a chemotherapy-first approach even in early stage PDAC, the validity of nodal parameters in post-treatment PD has been brought into question due to therapy-induced lymph node (LN) shrinkage. However, the available information is based on retrospective data or administrative registries, which only considered the number of examined and metastatic nodes, without detailed information regarding the dissection protocol and the influence of nodal metastases location. Back in 2013, corresponding to the standard lymphadenectomy definition release by the International Study Group of Pancreatic Surgery (ISGPS) and the diffusion of multi-agent chemotherapy regimens, an institutional, station-based nodal dissection protocol was established for post-neoadjuvant PD. The aim was to investigate whether the pattern of metastatic spread within the nodal basin is a superior quality metric for prognosis relative to the count-based classification system.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Standardization of Surgery on the Pancreatic Cancer

NCT00679913

Pancreatic Cancer

COMPLETED PHASE3

Margin Status After Pancreaticoduodenectomy for Cancer

NCT03267966

Pancreatic Cancer Cholangiocarcinoma Ampullary Cancer

COMPLETED NA

Reoperation After Pancreaticoduodenectomy

NCT04387903

Periampullary Carcinoma Pancreatic Cancer

UNKNOWN

Perioperative Cancer Cell Dissemination and Systemic Immune Suppression in Resectable Ductal Pancreatic Adenocarcinoma

NCT00495924

Pancreatic Neoplasms Adenocarcinoma Neoplasm Circulating Cells +2 more

COMPLETED

Surgery for Liver Metastases From PDAC

NCT05271110

Disseminated Pancreatic Cancer

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreas Cancer Pancreatic Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Systematic lymphadenectomy

The nodal dissection protocol included the ISGPS lymphadenectomy stations (5, 6, 8a, 12b-c, 13, 14a-b, and 17) extended to stations contiguous to the regional basin (8p, 12a-p, and jejunal mesentery nodes). Stations embedded in the PD specimen (13, 14a-b, 17 and jejunal mesentery LN) were defined as first nodal echelon, while stations sampled as distinct specimens (5, 6, 8a-p, 12a-b-p-c) were defined as second nodal echelon.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Post-neoadjuvant pancreatoduodenectomy for localized pancreatic ductal adenocarcinoma.

Exclusion Criteria

* Oligometastatic disease
* Upfront pancreatectomy
* Incomplete lymphadenectomy
* Macroscopically incomplete resections
* Rare variants of pancreatic cancer

Eligible Sex

ALL

Accepts Healthy Volunteers

No