WASH Trial: Intraoperative Lavage as a Treatment for Pancreatic Cancer

Summary

The goal of this clinical trial is to learn if a special washing treatment used during surgery can help people with pancreatic cancer live longer. The study includes adults who are having surgery for suspected pancreatic cancer or related cancers in nearby organs (called periampullary cancers).

The main questions it aims to answer are:

* Does the washing treatment improve overall survival (how long patients live)?
* Does it improve how long patients remain cancer-free and reduce cancer recurrence or complications?

The investigators will compare two types of washing treatments and standard care to see if either method improves outcomes.

Participants will:

Be assigned by chance (randomized) before surgery to one of three groups:

* Washing with warm saltwater (saline)
* Washing with sterile water
* No extensive washing (standard care)

Undergo their planned cancer surgery, during which the washing treatment (if assigned) will be performed right after the tumor is removed Be followed over time to monitor survival, cancer recurrence, and any side effects

The investigators estimate the washing treatment could increase average survival from about 18 months to 27 months. To ensure enough patients with confirmed pancreatic cancer are included, about 845 participants will be enrolled over time.

Conditions

• Acinar Cell Carcinoma
• Ampulla of Vater Adenocarcinoma
• Cholangiocarcinoma
• Duodenal Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Intraductal Papillary Mucinous Neoplasm
• Periampullary Adenocarcinoma

Interventions

PROCEDURE

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

OTHER

Lavage

Receive EAL-S

PROCEDURE

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

OTHER

Lavage

Receive EAL-W

PROCEDURE

Pancreatectomy

Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  lead OTHER

Principal Investigators

• Harish Lavu, MD · Thomas Jefferson University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-27

Primary Completion

2028-08-31

Completion

2031-05-31

Countries

• United States

Study Locations