Investigating a surgical technique to improve outcomes in pancreatic cancer surgery
Effect of Peri-adventitial SMA Dissection on Margin Status During Pancreaticoduodenectomy for Resectable Pancreatic Cancer
This study is testing a new surgical technique during pancreatic cancer surgery to see if it can help patients have better outcomes and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Birmingham NHS Foundation Trust Academic / other |
| Locations | 1 site (Birmingham, County (Optional)) |
| Trial ID | NCT04902352 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of peri-adventitial dissection of the superior mesenteric artery (SMA) during pancreaticoduodenectomy for patients with resectable pancreatic adenocarcinoma. The study will compare outcomes between patients who undergo this dissection technique and those who do not, focusing on the margin status of the surgical resection. Given the high rates of R1 resection and its association with poorer survival, the trial seeks to standardize this technique and provide evidence for its routine use. The ultimate goal is to improve surgical outcomes and patient survival rates.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older with non-metastatic pancreatic tumors of the head or uncinate process who are eligible for pancreaticoduodenectomy.
Not a fit: Patients with metastatic disease, borderline or locally advanced tumors, or those with other specific types of cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical margins and better survival rates for patients with pancreatic cancer.
How similar studies have performed: While the technique of peri-adventitial dissection has been practiced in various centers, this study aims to provide grade 1 evidence, making it a novel approach in the context of standardized surgical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult (≥ 18 years old) patients with a non-metastatic (based on NCCN definition) on imaging pancreatic tumour of the head or uncinate process treated with a pancreaticoduodenectomy Exclusion Criteria: 1. All paediatric patients (\< 18 years old) 2. Patients that cannot provide consent 3. All borderline, locally advanced and metastatic pancreatic tumours on imaging (based on NCCN criteria) 4. All patients with a cytological or histological diagnosis of cholangiocarcinoma, ampullary and duodenal carcinoma 5. All patients with benign disease or dysplasia with no evidence of malignancy
Where this trial is running
Birmingham, County (Optional)
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, County (Optional), United Kingdom (Recruiting)
Study contacts
- Study coordinator: Nikolaos A Chatzizacharias, FRCS
- Email: Nikolaos.Chatzizacharias@uhb.nhs.uk
- Phone: 07787731126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.