Surgical Results of Resection of Locally Advanced Pancreatic Cancer

Not yet recruiting

• Conditions: Pancreas Cancer
• Interventions: Procedure: Whipple operation

• Registration Number: NCT06206382
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study Start: 2024-01-05
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery after neoadjuvant chemotherapy for locally advanced pancreatic cancers	Whipple operation	-
Upfront surgery for locally advanced pancreatic cancers	Whipple operation	-

Primary Outcome Measures

Name	Time	Method
Mortality	3 years	Patient death

Secondary Outcome Measures

Name	Time	Method
Morbidity	6 months	Surgical complications