Clinical trial NCT02757859: High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery
Official title: The WASH Trial: A Randomized Trial of Abdominal Lavage Using Distilled Water or Saline at High Volumes for Resected Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acinar Cell Carcinoma
Ampulla of Vater Adenocarcinoma
Cholangiocarcinoma
Duodenal Adenocarcinoma
Pancreatic Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Pancreatic Intraductal Papillary Mucinous Neoplasm
Periampullary Adenocarcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 845
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, 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. standard 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 27 months after resection
Secondary outcomes:
measure: Incidence of overall complications and specific complications graded in severity using Common Terminology Criteria for Adverse Events (v4.0)
timeFrame: Up to 5 years after resection
measure: Disease Free survival
timeFrame: Up to 5 years after resection
measure: Recurrence free survival rate
timeFrame: At 1 year after resection
measure: Site of first recurrence
timeFrame: Up to 5 years after resection
Other outcomes:
measure: Presence of cells in cytologic washing
timeFrame: Up to 5 years
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Harish Lavu, MD
role: PRINCIPAL_INVESTIGATOR
References: