Mesopancreas Study in Pancreatic Cancer

NCT05895214 | Not Yet Recruiting DMC

• 1 other identifier: DRKS000295
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PDAC; Pancreatoduodenectomy; Margin, Resection; Surgery; Local Recurrent Tumor

Outcome Measures

Primary Outcomes (4)

• Rate of mesopancreatic infiltration in a multicentric setting.

  Rate of mesopancreatic fat infiltration

  through study completion, an average of 1 year

• 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

• 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

• 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 Outcomes (2)

• Rate of mesopancreatic infiltration in primary and borderline resectable pancreatic head carcinomas (classification of resectability using the well-known ABC scheme)

  through study completion, an average of 1 year

• 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).

  through study completion, an average of 1 year

Study Arms (2)

patients who received primary surgery

preoperative CT scans available for assessing resectability criteria and presumed mesopancreatic infiltration status (CT scans are centrally evaluated) UICC 8th edition staging including CRM Tumor size in mm measured twice perpendicular Age Sex CA 19-9 values (preoperative) ECOG status BMI Type of PD (tail preserved vs total PD) simultaneous vessel resection (complete, partial; combined arterial and venous)

Procedure: oncological relevance of the mesopancreas

patients who received neoadjuvant treatment prior to surgery

Peri-therapeutic CT scans available for assessing resectability criteria and presumed mesopancreatic infiltration status (CT scans are centrally evaluated) UICC 8th edition staging including CRM Tumor size in mm measured twice perpendicular Age Sex CA 19-9 values (peri-therapeutic) ECOG status BMI Type of neoadjuvant Therapy Type of PD (tail preserved vs total PD), simultaneous vessel resection (complete, partial; combined arterial and venous) Tumor response according to CAP

Procedure: oncological relevance of the mesopancreas

Interventions

oncological relevance of the mesopancreas PROCEDURE

Invasion status Invasion depth in mm Depth of mesopancreas in mm Treitz fascia intact (histopathological examination)

patients who received neoadjuvant treatment prior to surgery; patients who received primary surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive treated patients who are diagnosed with PDAC and received upfront surgical resection or neoadjuvant treatment prior to surgery

You may qualify if:

• 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)

You may not qualify if:

• Palliation
• Abort of operative procedure
• No preoperative computed-tomography for staging
• No pathological CRM Implementation according to the LEEPP

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf, Heinrich Heine University

Düsseldorf, Germany

Location

Related Publications (5)

• 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.

  PMID: 33775563 BACKGROUND

• 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.

  PMID: 34503170 BACKGROUND

• 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.

  PMID: 35008232 BACKGROUND

• 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.

  PMID: 18351300 BACKGROUND

• 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.

  PMID: 19590619 BACKGROUND

MeSH Terms

Conditions

Margins of Excision

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Sami Alexander Safi, MD

  Department of Surgery (A), University Hospital of Duesseldorf of the Heinrich Heine University Duesseldorf, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sami Alexander Safi, MD

CONTACT

+4916097937947; safi@hhu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: June 8, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 8, 2023

Record last verified: 2023-05

Locations

DE (1)