Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Local Recurrent Tumor | — | UNRESOLVED | — |
| Margin, Resection | — | UNRESOLVED | — |
| Pancreatoduodenectomy | — | UNRESOLVED | — |
| PDAC | Pancreatic Ductal Adenocarcinoma | ALIAS | 0.90 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oncological relevance of the mesopancreas | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients who received primary surgery
- description
- 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)
- interventionNames
- Procedure: oncological relevance of the mesopancreas
- label
- patients who received neoadjuvant treatment prior to surgery
- description
- 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
- interventionNames
- Procedure: oncological relevance of the mesopancreas
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDSafi 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
- BACKGROUNDSafi 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
- BACKGROUNDSafi 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
- BACKGROUNDEsposito 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
- BACKGROUNDMenon 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