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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival

Secondary outcome measures

Disease Free survival

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

Recurrence free survival rate

+1 more

Other outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,066 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,009 Total Patients Enrolled

Harish Lavu, MDPrincipal InvestigatorThomas Jefferson University

5 Previous Clinical Trials

840 Total Patients Enrolled

Media Library

Arm I (EIPL-S) Clinical Trial Eligibility Overview. Trial Name: NCT02757859 — N/A

Pancreatic Cancer Research Study Groups: Arm I (EIPL-S), Arm II (EIPL-D), ARM III (NO LAVAGE)

Pancreatic Cancer Clinical Trial 2023: Arm I (EIPL-S) Highlights & Side Effects. Trial Name: NCT02757859 — N/A

Arm I (EIPL-S) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02757859 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research trial?

"Affirmative. The information hosted on clinicaltrials.gov verifies that this medical trial was initially posted online in April 2016 and it is currently enrolling 667 patients from two separate sites. The study has also been recently edited in September 2022."

Answered by AI

What is the enrollment figure for this experiment?

"Affirmative. Clinicaltrials.gov exhibits that this study is actively enrolling members, having been posted on April 27th 2016 and updated as recently as September 7th 2022. 667 individuals from 2 centres are sought for the trial's duration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2016. "High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02757859.

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