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NCT05895214Not yet recruiting

Mesopancreas Study in Pancreatic Cancer

MESOPANC-01 Study: The Mesopancreas and the Ductal Adenocarcinoma of the Pancreatic Head: From Preoperative Imaging to Histopathological and Surgical Outcome

Source: ClinicalTrials.gov · Last updated 8 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 (registry)
Not yet recruiting
Study type
Observational
Enrollment
500 (estimated)
First submitted
25 Apr 2023
Start date
1 Jun 2023
Primary completion date
1 Jan 2025
Lead sponsor
Heinrich-Heine University, Duesseldorf
NCT number
NCT05895214

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 1 Jun 2023 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University Hospital Duesseldorf, Heinrich Heine University
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.