RECRUITING

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

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2016-04-27

Study Completion:2026-04-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02757859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Harish Lavu, MD

CONTACT

215-955-9402

Principal Investigator

Harish Lavu, MD

PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Study Locations (Sites)

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Harish Lavu, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04-27

Study Completion Date2026-04-27

Study Record Updates

Study Start Date2016-04-27

Study Completion Date2026-04-27

Terms related to this study

Additional Relevant MeSH Terms

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