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

Cholangiocarcinoma Clinical Trial

Official title:

The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02757859
• Other study ID #: 16D.083
• Secondary ID: NCI-2016-00588
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2016
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: Harish Lavu, MD
• Phone: 215-955-9402
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVES: I. Overall survival (OS) (18 to 27 months after resection). SECONDARY OBJECTIVES: I. Disease free survival (DFS). II. Complication rate. III. Site of first-recurrence (by site, and distant vs. local). IV. Clearance of malignant cells pre vs. post-lavage. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I (EIPL-S): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal saline (EIPL-S) lavage 10 times over 15 minutes. ARM II (EIPL-D): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive extensive intraoperative peritoneal distilled water (EIPL-D) lavage 10 times over 15 minutes. ARM III (NO LAVAGE): Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor. After completion of study treatment, patients are followed up every 3 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 845
• Est. completion date: January 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
• 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
• The subject is willing to consent to randomization of lavage vs. standard lavage

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 EIPL-S lavage vs. EIPL-D lavage vs. standard
• Known benign or indolent disease, including benign pancreatic cystic tumors or pancreatic endocrine tumors
• 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

Related Conditions & MeSH terms

• Acinar Cell Carcinoma
• Adenocarcinoma
• Ampulla of Vater Adenocarcinoma
• Cholangiocarcinoma
• Duodenal Adenocarcinoma
• Neoplasms, Cystic, Mucinous, and Serous
• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Periampullary Adenocarcinoma

Intervention

Procedure:
• Pancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Other:
• Lavage
Receive EIPL-S

Procedure:
• Pancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Other:
• Lavage
Receive EIPL-D

Procedure:
• Pancreatectomy
Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence of cells in cytologic washing	Will be modeled with repeated measures logistic regression using generalized estimating equations methods. Within this model, group differences in change from post-resection to post-lavage will be compared. McNemar's test for paired dichotomous data will be used to compare presence of cells at pre-dissection to post-resection.	Up to 5 years
Primary	Overall Survival	Will use a one-sided log-rank test to separately compare lavage (EIPL-S or EIPL=D) to no lavage with respect to OS. Assuming the study is not stopped at the interim analyses, the final comparison will be made with an alpha level of 0.02493. Distribution of OS will be estimated using the Kaplan-Meier method. Secondary analyses will use Cox regression to adjust the lavage/no lavage comparison for other baseline patient and/or characteristics known to be associated with OS.	Up to 27 months after resection
Secondary	Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)	Will use chi-square or Fisher's exact test for dichotomous outcomes and Poisson regression for count outcomes.	Up to 5 years after resection
Secondary	Disease Free survival	Will use log-rank tests for time-to-event outcomes.	Up to 5 years after resection
Secondary	Recurrence free survival rate		At 1 year after resection
Secondary	Site of first recurrence		Up to 5 years after resection

External Links

•   Thomas Jefferson University Hospital