Mesopancreas Study in Pancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
After the Introduction of the pathological circumferential resection margin (CRM status by LEEPP Protocol), residual cancer (R1 resection) was most often found in the dorsal and medial resection margins. Yet only the medial resection margin is preoperatively evaluated during staging, while the dorsal resection margin which embeds the mesopancreatic fat and thus resembles the area of the mesopancreas, is not considered during preoperative assessment for resectability. Local recurrence is similarly prevalent as systemic relapse, and revised lower rates of R0CRM- resections through the LEEPP protocol explained the poor local tumor control. The aim of this study is to interdisciplinary approach the circumferential infiltration status of the PDAC concentrating foremost on the mesopancreas of the dorsal resection margin by including anatomic and embryologic derived perspectives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients age ≥18 years who are admitted for primary surgery or patients who Received neoadjuvant therapy prior to surgery
CRM analysis through Pathologic Institute in study centre already implemented (see LEEPP protocol Menon et al (2009) Impact of margin status on survival following pancreatoduodenectomy for cancer: the Leeds Pathology Protocol (LEEPP). HPB 11(1):18-24)
Preoperative computed-tomographic Imaging (biphasic) prior to surgery (if resected without neoadjuvant treatment)
Pre-chemotherapeutic computed-tomographic and post-chemotherapeutic computed-tomographic if neoadjuvantly treated (biphasic).
Disqualifiers
Palliation
Abort of operative procedure
No preoperative computed-tomography for staging
No pathological CRM Implementation according to the LEEPP
Trial population
Consecutive treated patients who are diagnosed with PDAC and received upfront surgical resection or neoadjuvant treatment prior to surgery
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
oncological relevance of the mesopancreas
Procedure/SurgeryInvasion status Invasion depth in mm Depth of mesopancreas in mm Treitz fascia intact (histopathological examination)
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: patients who received primary surgery1 intervention
Group B: patients who received neoadjuvant treatment prior to surgery1 intervention
Trial outcomes
Primary outcomes
1
Rate of mesopancreatic infiltration in a multicentric setting.
Rate of mesopancreatic fat infiltration
Time frame
through study completion, an average of 1 year2
Statistical comparison of the mesopancreatic infiltration status with known oncologically relevant histopathological staging factors: is there a more aggressive tumor biology or an unfavorable tumor topography
Status of MP infiltration (pathologically analysed) vs. UICC and AJCC staging system (questionnaire from pathological staging reporting)
Time frame
through study completion, an average of 1 year3
Statistical comparison of mesopancreatic infiltration status with the CRM of the dorsal resection margin and with the entire CRM
Status of MP infiltration (pathologically analysed) vs. R-status (R0CRM- vs. R0CRM+/R1)(questionnaire from pathological staging reporting)
Time frame
through study completion, an average of 1 year4
Prediction value of density analyses in computed tomography (Hounsfield Unit) with mesopancreatic infiltration status in primary and neoadjuvantly patients
Density score of mesopancreas (HU) vs. Infiltration status of MP (Hounsfield Unit scale resembles the density assessment during computed tomography)(Hypothesis: higher HU measurements indicate higher risk for mesopancreatic fat infiltration) (minimum HU value: air -1000HU, maximum HU value: gold +30000 HU)
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Rate of mesopancreatic infiltration in primary and borderline resectable pancreatic head carcinomas (classification of resectability using the well-known ABC scheme)
Status of MP infiltration vs. resectability status
Time frame
through study completion, an average of 1 year2
Incidence rate of mesopancreatic infiltration between neoadjuvant treated and primary resected patients (matched-pairs analysis: both patient groups (neoadjuvant vs. primary resected) must have similar resectability criteria).
Status of MP infiltration vs. treatment protocol (matched pair analysis)
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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