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Abdominal Lavage for Resectable Pancreatic Cancer

N/A

Recruiting

Led By Harish Lavu, MD

Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)

A diagnosis of pancreatic or other periampullary cancer is suspected preoperatively

Must not have

Evidence of metastatic disease

Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial studies how well washing the abdomen works in increasing survival after surgery in patients with pancreatic cancer.

Who is the study for?

This trial is for adults with suspected pancreatic or periampullary cancer who need surgery (pancreatectomy) and have no medical reasons to avoid it. Patients must be willing to be randomly assigned to different washing procedures after surgery. Those with benign tumors, other cancers within the last five years, or metastatic disease cannot join.

What is being tested?

The study tests if high volume abdominal washings after pancreatectomy can increase survival in patients with removable pancreatic cancer. Participants will either receive this new method of washing or the standard one, decided by chance.

What are the potential side effects?

Potential side effects are not specified for the high volume lavage procedure but may include typical post-surgical risks such as infection, bleeding, and reactions related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am recommended to undergo surgery for my pancreas.

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I am suspected to have pancreatic or nearby cancer before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have a non-cancerous or slow-growing pancreatic tumor.

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I am under 18 years old.

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I am not recommended to have surgery to remove my pancreas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

Disease Free survival

Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)

Other study objectives

Presence of cells in cytologic washing

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Arm I (EIPL-S)Active Control2 Interventions

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes.

Group II: Arm II (EIPL-D)Active Control2 Interventions

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes.

Group III: ARM III (NO LAVAGE)Placebo Group1 Intervention

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.

0 / 6Eligibility criteria met