- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2016-02
2018-12-19
2018-12-19
154
NCT02803814
Fundación para la Investigación del Hospital Clínico de Valencia
Fundación para la Investigación del Hospital Clínico de Valencia
INTERVENTIONAL
Pancreatoduodenectomy in Pancreatic and Periampullary Tumors
Background: Recently it has been observed in pancreatic cancer that after apparently complete surgical resection, histological examination of the surgical specimen according to a standard protocol reveals tumor infiltration of the surgical margin in more than 50% of patients. To increase the resection margin and reduce such high infiltration rate, a new surgical approach based on the initial dissection of the superior mesenteric artery has been advocated. Aims: To compare the rate of free resection margin (R0) and oncological results of two possible approaches to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area: the classic approach versus the initial approach of the superior mesenteric artery. Methodology: Prospective, randomized, multicenter study in which patients with pancreatic and periampullary tumors undergo a pancreaticoduodenectomy. In a group the classical approach from the superior mesenteric vein will be performed and in the other group an initially dissecting the superior mesenteric artery approach will be carried out. 116 patients are required and the main variables considered are: free margin rates (R0) or infiltrated by tumor (R1), postoperative morbidity, mortality, local and systemic recurrence, disease-free interval and survival at 1, 3 and 5 years.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-05-23 | N/A | 2020-07-21 |
2016-06-14 | N/A | 2020-07-22 |
2016-06-17 | N/A | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Superior mesenteric artery approach Initial approach of the superior mesenteric artery to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area | PROCEDURE: Superior mesenteric artery approach for pancreatoduodenectomy
|
| ACTIVE_COMPARATOR: Classic approach Classic approach to perform a pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area | PROCEDURE: Classic approach for pancreatoduodenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Rate of free resection margin (R0) | Histological examination of the surgical specimen | 1 month |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
