Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Ohio
Case Western Reserve University
RECRUITING
Cleveland
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
Harish Lavu, MD
215-955-9402
Time Frame
Start Date: 2016-04-27
Estimated Completion Date: 2026-04-27
Participants
Target number of participants: 845
Treatments
Active_comparator: Arm I (EIPL-S)
Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-S lavage 10 times over 15 minutes.
Active_comparator: Arm II (EIPL-D)
Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy. Immediately after removal of tumor, patients receive EIPL-D lavage 10 times over 15 minutes.
Sham_comparator: ARM III (NO LAVAGE)
Patients undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy with no extensive lavage after removal of tumor.
Sponsors
Leads: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

This content was sourced from clinicaltrials.gov