WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer

PRIMARY OBJECTIVE:

To compare overall survival (OS) following pancreatic resection between subjects receiving extensive abdominal lavage with saline (EAL-S), extensive abdominal lavage with distilled water (EAL-W), and standard of care without extensive lavage.

SECONDARY OBJECTIVES:

I. Disease-free survival (DFS). II. Complication rate. III. Site of first recurrence (by site and distant versus local recurrence). IV. Clearance of malignant cells pre- versus post-lavage.

STUDY DESIGN:

This is a prospective, randomized, participant-blinded clinical trial evaluating extensive abdominal lavage during pancreatic resection for pancreatic and periampullary malignancies.

Subjects are enrolled preoperatively and randomized prior to entering the operating room. Randomization is stratified by study site and use of neoadjuvant therapy. Subjects are randomized to one of three treatment arms:

Arm I (EAL-S): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed 0.9% normal saline administered as ten sequential 1-liter irrigations with aspiration.

Arm II (EAL-W): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy followed immediately after specimen removal by extensive abdominal lavage using 10 liters of warmed distilled water administered as ten sequential 1-liter irrigations with aspiration.

Arm III (Standard of Care/No Extensive Lavage): Subjects undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy without protocol-directed extensive lavage following specimen removal.

The extensive lavage procedure is performed immediately after specimen removal and generally requires approximately 15 minutes.

A total of 845 subjects were enrolled. Subjects with suspected pancreatic or periampullary malignancy are enrolled preoperatively because definitive diagnosis cannot be established before resection. The primary efficacy analysis population consists of subjects with resected pancreatic cancer according to protocol-defined criteria.

For approximately the first 200 enrolled subjects, cytologic washings are obtained at predefined intraoperative time points (pre-dissection, post-resection, post-lavage, and specimen washing) for correlative analyses evaluating malignant cell clearance. Additional biologic studies may be performed using collected specimens.

Following completion of study treatment, subjects are followed initially at approximately 30 days after surgery and then every 3 months thereafter for survival, recurrence, postoperative outcomes, and adjuvant treatment information for up to 5 years following surgery or until death, whichever occurs first.

Inclusion criteria

• The subject has a surgical indication for pancreatectomy (pancreaticoduodenctomy, distal pancreatectomy, total pancreatectomy) as determined by the treating physician/surgeon
• 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
• Age ≥18 years of age.
• The subject is willing to consent to randomization of EAL-S vs. EAL-W vs. no extensive lavage (SOC)

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 EAL-S vs. EAL-W vs. no extensive lavage (SOC)
• Known benign or indolent disease (including benign pancreatic cystic tumors or pancreatic endocrine tumors) without possible risk of malignancy
• 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 preoperatively