High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery

Launched by SIDNEY KIMMEL CANCER CENTER AT THOMAS JEFFERSON UNIVERSITY · Apr 29, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new procedure called high volume washing of the abdomen to see if it can help patients with pancreatic cancer live longer after surgery. During this procedure, doctors wash the inside of the abdomen with a large amount of fluid to remove any loose cancer cells that might remain after the tumor is taken out. The hope is that this extra step will improve survival rates for patients who have pancreatic or related cancers that can be surgically removed.

To participate in this trial, patients need to be at least 18 years old and scheduled for surgery to remove their pancreatic cancer. They should not have any medical reasons that would prevent them from having surgery, and they must be willing to be randomly assigned to one of three treatment groups. Participants can expect to be part of a study that evaluates the effectiveness of this washing procedure compared to standard care. If you or a loved one are considering joining this trial, it's important to discuss it with your doctor to understand if it's a good option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy) as determined by the treating physician/surgeon
• • A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively
• • In the opinion of the surgeon, the subject has no medical contraindications to pancreatectomy
• • Age ≥18 years of age.
• • The subject is willing to consent to randomization of EAL-S vs. standard EAL-W vs. no extensive lavage. (SOC)
• Exclusion Criteria:
• • The subject does not have a surgical indication for pancreatectomy
• • In the opinion of the surgeon, the subject has medical contraindications to pancreatectomy
• • Age \< 18 years of age
• • The subject is not willing to consent to EAL-S vs. EAL-W vs. no extensive lavage (SOC)
• • Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors) without possible risk of malignancy
• • Other malignancy within five years, unless the probability of recurrence of the prior malignancy is \< 5% as determined by the principal investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.
• • Evidence of metastatic disease preoperatively.