Active not recruitingNAINTERVENTIONAL

The DISSECT Study: Effect of Peri-aDventItial SMA diSsECtion on Margin sTatus During Pancreaticoduodenectomy for Resectable Pancreatic Cancer

This study, called DISSECT, is for patients with a specific type of pancreatic cancer who are having surgery. Pancreatic cancer surgery can sometimes leave behind tiny cancer cells, known as an R1 resection, which can affect recovery. This often happens near a major blood vessel called the Superior Mesenteric Artery (SMA). The study aims to compare two surgical approaches around the SMA: one that involves a special, more thorough dissection (peri-adventitial dissection) and one that doesn't. Researchers want to find out if this special dissection helps ensure all cancer cells are removed, which could lead to better outcomes for patients. It's a randomised controlled trial, meaning some patients will have the special dissection and some won't, to see which approach is more effective.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Birmingham NHS Foundation Trust

Enrolment target

102

Start

06 Apr 2021

Estimated completion

06 Oct 2026

Pancreatic Adenocarcinoma

What is this study about?

Pancreatic cancer can be a very challenging disease. For some patients, surgery to remove the tumour is an option, which can offer the best chance of a good outcome. This particular operation, called a pancreaticoduodenectomy, involves removing the head of the pancreas where the tumour is often located. A key challenge during this surgery is ensuring that all cancer cells are removed, leaving what surgeons call 'clear margins'. If tiny cancer cells are left behind, categorised as an R1 resection, it can sadly mean the cancer is more likely to return and limit how well treatment works in the long run. One area where these remaining cancer cells are often found is near a major blood vessel called the Superior Mesenteric Artery (SMA).

Doctors are always looking for better ways to perform these surgeries. One technique that has been suggested involves a very careful and thorough dissection around the SMA, known as 'peri-adventitial dissection'. The idea is that by being extra meticulous in this area, surgeons might be more successful at removing all cancer cells. However, this technique isn't routinely used by everyone, and there isn't enough strong evidence yet to say for sure if it makes a significant difference. There are also theoretical risks associated with this more extensive dissection, such as potential damage to blood vessels or other issues.

This study, called DISSECT, is a randomised controlled trial. This means that patients taking part will be randomly assigned to one of two groups: one group will have the standard surgical approach, and the other will have the additional peri-adventitial dissection around the SMA. By comparing these two groups, the researchers hope to understand if this special dissection can reduce the number of cases where tiny cancer cells are left behind (R1 resections) and ultimately improve patient outcomes. This research is vital for improving how pancreatic cancer surgery is performed in the future.

Key takeaways

This study evaluates a new surgical technique for pancreatic cancer.
It aims to improve complete removal of cancer cells during surgery.
Patients with pancreatic cancer suitable for surgery may be eligible.
It's a randomised trial, comparing a standard approach with an enhanced dissection.
The goal is to improve patient outcomes by achieving 'clear margins'.
Participation would involve undergoing one of two surgical methods.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. You must have been diagnosed with pancreatic cancer that has not spread to other parts of your body, specifically located in the head of the pancreas, and suitable for surgical removal. This is based on specific criteria determined by your medical team after reviewing your scans and health information.

You would not be able to join the study if you are under 18 years old. Also, if you have a type of pancreatic cancer that has already spread or is too advanced for surgery, you would not be eligible. The study is specifically for pancreatic adenocarcinoma, so if your cancer is a different type, such as cholangiocarcinoma or ampullary cancer, you would not qualify. Finally, if you have a benign (non-cancerous) condition or are unable to give your informed consent to participate, you cannot join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with pancreatic cancer in the head of your pancreas?
Has your medical team determined your cancer is suitable for surgery and has not spread?
Is your cancer specifically pancreatic adenocarcinoma (not another type)?
Are you able to agree to take part in the study?

Answer every question to see your result.

What does participation involve?

Details about participation, such as specific visits, assessments, medication, or follow-up, are not provided in this summary. However, in a typical surgical trial, this would likely involve pre-operative appointments, the surgery itself (where one of the two techniques would be used), and regular follow-up appointments after surgery to monitor your recovery and long-term health. The total duration of your involvement, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Participating in research studies always carries potential benefits and risks. A potential benefit of this study is that the specialised surgical technique being investigated might lead to a more complete removal of your cancer. However, this technique also carries theoretical risks, such as an increased chance of bleeding or damage to blood vessels during surgery. All participants will receive high-quality medical care, regardless of which group they are in. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom

Common questions

What is an 'R1 resection'?

An R1 resection means that after surgery, when the removed tissue is looked at under a microscope, tiny cancer cells were found at the very edge, or 'margin', of where the surgeon cut.

What is the SMA?

The SMA stands for Superior Mesenteric Artery. It's a major blood vessel that supplies blood to parts of your intestines and pancreas, and it's an important area for surgeons to consider during pancreatic cancer operations.

What does 'randomised controlled trial' mean?

It means patients are put into different treatment groups by chance, like flipping a coin. This helps make sure the results are fair and reliable, so we can see if one treatment is truly better than another.

Will I know which surgical technique I received?

The information provided doesn't state whether patients are told which technique they received. This is something the study team would explain during the consent process.

Why is this study important?

This study is important because it aims to find out if a specific surgical technique can help remove all cancer cells more effectively, which could lead to better long-term outcomes for people undergoing pancreatic cancer surgery.