Abdominal Lavage for Resectable Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Harish Lavu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Disqualifiers: Benign disease, Other malignancy, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

845 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized clinical trial studies how well high volume washing of the abdomen works in increasing survival after surgery in patients with pancreatic cancer that can be removed by surgery. High volume washings may remove free floating cancers present after surgery and help prolong survival in patients with pancreatic cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is abdominal lavage different from other treatments for resectable pancreatic cancer?

Abdominal lavage for resectable pancreatic cancer is unique because it involves washing out the abdominal cavity to check for cancer cells, which helps predict the patient's prognosis and guide treatment decisions. This approach is different from standard treatments that focus on directly removing or targeting the tumor itself. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Abdominal Lavage for Resectable Pancreatic Cancer?

Peritoneal lavage has been shown to help decrease pain and amylase levels (an enzyme related to the pancreas) in patients with severe acute pancreatitis, although it did not improve survival rates significantly. However, its effectiveness in preventing complications or improving outcomes in pancreatic cancer surgery is not well-supported by current evidence. ^{1 2 3 6 7}

Who Is on the Research Team?

Harish Lavu, MD

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am recommended to undergo surgery for my pancreas.

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

The subject is willing to consent to randomization of lavage vs. standard lavage

Exclusion Criteria

I am not willing to agree to different types of lung lavage treatments.

I am under 18 years old.

My cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Depending on the arm, they receive either EIPL-S lavage, EIPL-D lavage, or no lavage.

Immediate post-surgery

1 visit (in-person)

Follow-up

Participants are monitored for overall survival, disease-free survival, and complications every 3 months.

Up to 5 years

Every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lavage

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (EIPL-S) Active Control 2 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 Control 2 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 Group 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 64 patients with severe acute pancreatitis, early resective surgery was linked to high mortality, especially in those with necro-hemorrhagic pancreatitis and respiratory failure.

Peritoneal lavage, performed earlier in survivors, effectively reduced pain and amylase levels but did not improve hypoxemia; the overall survival rate was 50% at one month, with poor outcomes associated with factors like age over 50 and delayed treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term survival in severe acute pancreatitis. Role of peritoneal lavage and conservative surgery]. Videla, C., Cenitagoya, G., Bergh, C., et al.[2006]

In a study of 104 patients undergoing pancreatic surgery, those who received intraoperative peritoneal lavage had a significantly higher rate of surgical site infections (35%) compared to those who did not receive lavage (15%).

The use of lavage did not reduce the frequency of peritoneal recurrence in patients with pancreatic and biliary cancers, indicating that lavage may not provide the intended benefits in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure of peritoneal lavage to prevent operative site infection and peritoneal tumor recurrence in pancreatic surgery. Ishihara, M., Nakamura, A., Takahashi, Y., et al.[2023]

In a study of 39 patients with resectable left-sided pancreatic cancer, 12.8% had malignant cells in peritoneal lavage samples, which was more common in those with vascular invasion.

Positive cytology in peritoneal lavage was linked to significantly lower overall and recurrence-free survival rates, making it an important independent prognostic factor for cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of peritoneal lavage cytology in resectable left-sided pancreatic cancer. Iwagami, Y., Eguchi, H., Wada, H., et al.[2021]

In a study of 202 patients with locally advanced pancreatic cancer, peritoneal lavage cytology identified 29% of patients as having stage IV disease, which is associated with a significantly worse median survival of 11 months compared to 16 months for those not upstaged.

Positive cytology results were found to be an independent predictor of poorer survival outcomes, suggesting that peritoneal lavage cytology could be a valuable tool in guiding treatment decisions for patients with locally advanced pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive peritoneal lavage cytology is a predictor of worse survival in locally advanced pancreatic cancer. Clark, CJ., Traverso, LW.[2010]

In a study of 399 pancreatic cancer patients who underwent pre-resection lavage, 10.8% tested positive for malignant cells, indicating a poor prognosis similar to metastatic disease.

Higher initial serum Ca19-9 levels (greater than 1220 U/mL), locally advanced disease, and a BMI of 25 kg/m2 or more were identified as significant predictors of positive peritoneal cytology, suggesting these factors could help identify patients at greater risk before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting positive peritoneal cytology in pancreatic cancer. O'Halloran, EA., Board, T., Lefton, M., et al.[2022]

In a review of 4905 patients with pancreatic cancer, 7.8% had positive peritoneal lavage cytology (CY+), which was associated with significantly poorer overall survival and higher recurrence rates, indicating a worse prognosis for these patients.

Despite the negative implications of CY+, the evidence suggests that it should not automatically prevent curative surgical resection, highlighting the need for further high-quality studies to explore treatment options for patients with resectable CY+.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should Positive Cytology Revealed by Intraoperative Lavage Preclude Radical Resection in Resectable Pancreatic Cancer?: A Systemic Review and Meta-analysis. Li, BQ., Wang, HY., Li, L., et al.[2023]

In a study of 151 patients with pancreatic cancer, positive cytologic findings in peritoneal washings were found in 23.8% of cases and were significantly associated with more advanced disease, impacting survival outcomes.

For patients without visible metastases, those with positive cytologic findings showed better survival and peritoneal metastases-free survival when treated with chemoradiotherapy compared to those in the resectable group, suggesting a potential benefit of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic value of cytologic examination of peritoneal washings in pancreatic cancer. Konishi, M., Kinoshita, T., Nakagohri, T., et al.[2019]

Citations

1. Chile pubmed.ncbi.nlm.nih.gov

[Short-term survival in severe acute pancreatitis. Role of peritoneal lavage and conservative surgery]. [2006]

2. Germany pubmed.ncbi.nlm.nih.gov

Failure of peritoneal lavage to prevent operative site infection and peritoneal tumor recurrence in pancreatic surgery. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

Implications of peritoneal lavage cytology in resectable left-sided pancreatic cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Positive peritoneal lavage cytology is a predictor of worse survival in locally advanced pancreatic cancer. [2010]

5. Germany pubmed.ncbi.nlm.nih.gov

Predicting positive peritoneal cytology in pancreatic cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Should Positive Cytology Revealed by Intraoperative Lavage Preclude Radical Resection in Resectable Pancreatic Cancer?: A Systemic Review and Meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Prognostic value of cytologic examination of peritoneal washings in pancreatic cancer. [2019]