Surgery Clinical Trial
— MESOPANC-01Official title:
MESOPANC-01 Study: The Mesopancreas and the Ductal Adenocarcinoma of the Pancreatic Head: From Preoperative Imaging to Histopathological and Surgical Outcome
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | January 1, 2027 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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). - indepth information of surgical procedure (pancreatic tail preserved:yes/no, pylorus preserved resection: yes/no, venous resection: complete/partial/no, arterial resection: complete/partial/no) Exclusion Criteria: - Palliation - Abort of operative procedure - No preoperative computed-tomography for staging - No pathological CRM Implementation according to the LEEPP |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Duesseldorf, Heinrich Heine University | Duesseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Esposito I, Kleeff J, Bergmann F, Reiser C, Herpel E, Friess H, Schirmacher P, Buchler MW. Most pancreatic cancer resections are R1 resections. Ann Surg Oncol. 2008 Jun;15(6):1651-60. doi: 10.1245/s10434-008-9839-8. Epub 2008 Mar 20. — View Citation
Menon KV, Gomez D, Smith AM, Anthoney A, Verbeke CS. Impact of margin status on survival following pancreatoduodenectomy for cancer: the Leeds Pathology Protocol (LEEPP). HPB (Oxford). 2009 Feb;11(1):18-24. doi: 10.1111/j.1477-2574.2008.00013.x. — View Citation
Safi SA, Haeberle L, Fluegen G, Lehwald-Tywuschik N, Krieg A, Keitel V, Luedde T, Esposito I, Rehders A, Knoefel WT. Mesopancreatic excision for pancreatic ductal adenocarcinoma improves local disease control and survival. Pancreatology. 2021 Jun;21(4):787-795. doi: 10.1016/j.pan.2021.02.024. Epub 2021 Mar 17. — View Citation
Safi SA, Haeberle L, Heuveldop S, Kroepil P, Fung S, Rehders A, Keitel V, Luedde T, Fuerst G, Esposito I, Ziayee F, Antoch G, Knoefel WT, Fluegen G. Pre-Operative MDCT Staging Predicts Mesopancreatic Fat Infiltration-A Novel Marker for Neoadjuvant Treatment? Cancers (Basel). 2021 Aug 28;13(17):4361. doi: 10.3390/cancers13174361. — View Citation
Safi SA, Haeberle L, Rehders A, Fung S, Vaghiri S, Roderburg C, Luedde T, Ziayee F, Esposito I, Fluegen G, Knoefel WT. Neoadjuvant Treatment Lowers the Risk of Mesopancreatic Fat Infiltration and Local Recurrence in Patients with Pancreatic Cancer. Cancers (Basel). 2021 Dec 23;14(1):68. doi: 10.3390/cancers14010068. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of mesopancreatic infiltration in a multicentric setting. | Rate of mesopancreatic fat infiltration | through study completion, an average of 1 year | |
Primary | 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) | through study completion, an average of 1 year | |
Primary | 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) | through study completion, an average of 1 year | |
Primary | 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) | through study completion, an average of 1 year | |
Secondary | 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 | through study completion, an average of 1 year | |
Secondary | 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) | through study completion, an average of 1 year |
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