Surgical Results of Resection of Locally Advanced Pancreatic Cancer

Pancreas Cancer Clinical Trial

Official title:

Surgical Outcome of Borderline Resectable Pancreatic Cancer: Upfront Surgery Versus Neoadjuvant Chemotherapy (Single Center Experience)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06206382
• Other study ID #: Borderline pancreatic cancer
• Status: Not yet recruiting
• Start date: January 5, 2024
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: Mina Yosef, Master
• Phone: +201224807616
• Email: minamelad1987[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to compare the surgical outcomes between upfront surgery and surgery after neoadjuvant chemotherapy in terms of morbidity and mortality

Description:

Pancreatic cancer is the fourth leading cause of cancer death in the United States. While surgical resection remains the only curative option, more than 80% of patients present with unresectable disease. Unfortunately, even among those who undergo resection, the reported median survival is 15-23 mo, with a 5-year survival of approximately 20%. Disappointingly, over the past several decades, despite improvements in diagnostic imaging, surgical technique and chemotherapeutic options, only modest improvements in survival have been realized. Nevertheless, it remains clear that surgical resection is a prerequisite for achieving long-term survival and cure. The concept of borderline resectable pancreatic cancer has evolved from several clinical observations made over decades. It has been recognized for some time that the prognosis for patients undergoing surgical resection for pancreatic ductal adenocarcinoma (PDAC) is highly dependent on margin status, with total gross excision and histologically negative margins (R0 resection) being associated with the best outcomes. Survival for patients who undergo total gross excision but have histologically positive margins (R1 resection) have a reduced survival in most series

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients under surgical management for pancreatic cancer
• Patients whose radiological findings are compatible with resectability of the tumour including vascular encasement

Exclusion Criteria:

• Patients who are medically unfit for surgery
• Patients whose radioliogical findins suggestive of unresectability of the tumour including vascular abutment or infiltration more than 180 dergree

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Whipple operation
Whipple operation is the surgery used for pancreatic head cancer in the form of pancreaticoduodenectomy then reconstruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

Han S, Choi DW, Choi SH, Heo JS, Han IW, You YH. Long-term outcomes following en bloc resection for pancreatic ductal adenocarcinoma of the head with portomesenteric venous invasion. Asian J Surg. 2021 Jan;44(1):313-320. doi: 10.1016/j.asjsur.2020.07.021. Epub 2020 Sep 21. — View Citation

Lapshyn H, Schulte T, Petruch N, Petrova E, Honselmann K, Deichmann S, Braun R, Kulemann B, Hoeppner J, Rades D, Keck T, Wellner UF, Bausch D, Bolm L. Postoperative Outcomes of Tangential versus Segmental Resection and End-to-end Reconstruction of the Superior Mesenterico-Portal Vein During Pancreatoduodenectomy for Pancreatic Adenocarcinoma: A Single-Center Experience. Anticancer Res. 2021 Oct;41(10):5123-5130. doi: 10.21873/anticanres.15329. — View Citation

Tewari M. Significance of pathological positive superior mesenteric/portal venous invasion in pancreatic cancer. Hepatobiliary Pancreat Dis Int. 2016 Dec;15(6):572-578. doi: 10.1016/s1499-3872(16)60156-x. — View Citation

Wang WL, Ye S, Yan S, Shen Y, Zhang M, Wu J, Zheng SS. Pancreaticoduodenectomy with portal vein/superior mesenteric vein resection for patients with pancreatic cancer with venous invasion. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):429-35. doi: 10.1016/s1499-3872(15)60400-3. — View Citation

Yu XZ, Li J, Fu DL, Di Y, Yang F, Hao SJ, Jin C. Benefit from synchronous portal-superior mesenteric vein resection during pancreaticoduodenectomy for cancer: a meta-analysis. Eur J Surg Oncol. 2014 Apr;40(4):371-8. doi: 10.1016/j.ejso.2014.01.010. Epub 2014 Feb 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patient death	3 years
Secondary	Morbidity	Surgical complications	6 months