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 trial tests whether a high-volume wash of the abdomen during surgery can extend the lives of people with pancreatic cancer. After removing the cancerous part of the pancreas, some patients will receive this special wash, known as abdominal lavage, to determine if it clears out any remaining cancer cells. The trial includes three groups: one with the wash, one with a different type of wash, and one without any wash. It seeks participants who require pancreatic surgery and have been diagnosed with pancreatic or nearby cancers.

As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative research that may enhance future cancer treatments.

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.

What prior data suggests that abdominal lavage is safe for patients with resectable pancreatic cancer?

Research has shown that both EIPL-S and EIPL-D wash treatments are generally well-tolerated by patients. In previous studies, patients who received these wash treatments during pancreatic cancer surgery did not experience more complications compared to those who didn’t receive the wash. This indicates that the treatments did not cause additional problems during recovery.

Specifically, one study found no difference in post-surgery issues between the group that received EIPL-S and the group that did not. In contrast, EIPL-D has been shown to lower the risk of death and reduce pain after surgery when used alongside the operation.

While these treatments are still under investigation, current evidence suggests they are safe and do not add extra risk during surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of using extensive intraoperative peritoneal lavage (EIPL) in patients undergoing surgery for resectable pancreatic cancer. This approach is unique because it involves washing out the abdominal cavity with a saline solution multiple times right after tumor removal, which isn't a standard part of current surgical procedures for pancreatic cancer. The goal is to reduce microscopic tumor cells that might remain after surgery, potentially decreasing the risk of cancer recurrence. By comparing different lavage techniques to the standard surgical approach without lavage, researchers aim to determine if this method can improve surgical outcomes and long-term survival for patients.

What evidence suggests that abdominal lavage is effective for increasing survival in resectable pancreatic cancer?

In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of lavage techniques. Earlier research has shown that EIPL-S lavage greatly reduces the chances of cancer returning in the abdomen after pancreatic cancer surgery. It might also lower the risk of death and reduce post-surgery pain. Some researchers have found that using EIPL with chemotherapy can lead to better patient outcomes. Participants in this trial may receive EIPL-S lavage.

For those in the EIPL-D lavage arm, it has significantly reduced cancer recurrence after surgery. However, some studies suggest that EIPL might not improve survival or short-term results. Overall, EIPL shows promise, but results vary, so further study is needed. Another group in this trial will undergo surgery without extensive lavage to serve as a comparator. ^{1 2 3 4 6}

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 under 18 years old.

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

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 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 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 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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16211228/

EIPL (Extensive Intraoperative Peritoneal Lavage) Therapy ... EIPL (Extensive Intraoperative Peritoneal Lavage) Therapy Significantly Reduces Peritoneal Recurrence After Pancreatectomy in Patients With Pancreatic Cancer.

2. wjgnet.com wjgnet.com/1948-9366/full/v15/i3/430.htm

Efficacy and outcome of extensive intraoperative peritoneal ... EIPL could benefit advanced GC patients because it is inexpensive and easy and would be a promising therapeutic strategy in the future.

3. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2024/12000/extensive_intraoperative_peritoneal_lavage_with.60.aspx

Extensive intraoperative peritoneal lavage with surgery,... While there is a marginal difference in survival outcomes, EIPL holds promise in significantly reducing overall cancer recurrence and suggests ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10080594/

Efficacy and outcome of extensive intraoperative peritoneal ... Some researchers found that extensive intraoperative peritoneal lavage (EIPL) plus intraperitoneal chemotherapy can improve the prognosis of patients.

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.715040/full

Does Extended Intraoperative Peritoneal Lavage Really ... Conclusions: EIPL did not bring benefit in terms of short-term outcomes or survival. Therefore, EIPL is not recommended for patients undergoing curative ...

6. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2729452

Combined Surgery and Extensive Intraoperative Peritoneal ... Patients receiving surgery plus lavage also exhibited reduced mortality and postoperative pain compared with those receiving surgery alone.