Surgical Results of Resection of Locally Advanced Pancreatic Cancer

NCT ID: NCT06206382

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-05

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Pancreas Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upfront surgery for locally advanced pancreatic cancers

Whipple operation

Intervention Type PROCEDURE

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

Surgery after neoadjuvant chemotherapy for locally advanced pancreatic cancers

Whipple operation

Intervention Type PROCEDURE

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

Interventions

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Whipple operation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mina Melad Boshra Yosef

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mina Yosef, Master

Role: CONTACT

+201224807616

References

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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.

Reference Type BACKGROUND
PMID: 26256089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32972828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34593463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24560302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27919845 (View on PubMed)

Other Identifiers

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Borderline pancreatic cancer

Identifier Type: -

Identifier Source: org_study_id

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