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临床试验/NCT05895214
NCT05895214尚未招募不适用

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

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
Rate of mesopancreatic infiltration in a multicentric setting.

研究概览

简要总结

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.

详细描述

For patients with a ductal adenocarcinoma of the pancreatic head (PDAC) pathological evaluation of the pancreatoduodenectomy specimen has endured a redefined process. After the Introduction of the pathological circumferential resection margin, residual cancer (R1 resection) was most often found in the dorsal and medial resection margins. Yet only the medial resection margin is preoperatively evaluated by staging and utilized during assessment of resectability. The dorsal resection margin which resides residual cancer (R1 resection) at a similar rate compared to the medial resection margin, is not considered during preoperative assessment for resectability. After the inclusion of the pathological LEEPP protocol true R0 resection rates have dropped to ~30%.

Next to the poor systemic tumor control and thus early detected relapse in PDAC patients, local recurrence is evenly at risk and remains an ungoing dilemma. Revised pathological outcome by the implemented LEEPP protocol explains 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 dorsal resection margin by including anatomic and embryologic derived perspectives.

These perspectives have already been implemented by complete mesocolic and total mesorectal excision. The mesocolon of the ascending colon is embedded dorsally by fascia sheets, resulted by the embryologic fusion process, and the anatomic landmark of this fascia sheet has gained significant clinical relevance for radical surgical resection (Toldt fascia for total mesocolic excision). While surgical perspectives for the colorectal system have included the anatomic and embryologic nature of the colon and rectum, these landmarks and the idea of ''compartment anatomy'' are not implemented during pancreatoduodenectomy.

It seems rational to suggest that redefined surgical standards for colorectal cancer patients with implemented fascial sheets as anatomic landmarks could be translated to the pancreas as well. Similar to the ascending colon; the pancreas remains secondary retroperitoneal. The Treitz fascia is a cranio-medial extension of the toldts fascia, which again is an anatomic landmark for total mesocolic excision. The superior mesenteric artery serves as an anchor point for the embryologic rotation process of the pancreas until it remains secondary retroperitoneal. From an anatomic and embryologic point of view, there should not be any doubt for the existence of a mesopancreas.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Rate of mesopancreatic infiltration in a multicentric setting.

时间窗: through study completion, an average of 1 year

Rate of mesopancreatic fat infiltration

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

时间窗: through study completion, an average of 1 year

Status of MP infiltration (pathologically analysed) vs. UICC and AJCC staging system (questionnaire from pathological staging reporting)

Prediction value of density analyses in computed tomography (Hounsfield Unit) with mesopancreatic infiltration status in primary and neoadjuvantly patients

时间窗: through study completion, an average of 1 year

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)

Statistical comparison of mesopancreatic infiltration status with the CRM of the dorsal resection margin and with the entire CRM

时间窗: through study completion, an average of 1 year

Status of MP infiltration (pathologically analysed) vs. R-status (R0CRM- vs. R0CRM+/R1)(questionnaire from pathological staging reporting)

次要结局

  • 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)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (1)

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