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3% saline for Pancreaticoduodenectomy

Phase 2
Waitlist Available
Led By Harish Lavu, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Study Summary

The Whipple operation is a complex surgical procedure involving the removal of the head of the pancreas, bile duct, and a portion of the intestine (duodenum) that is performed for patients who have cancer or some other condition affecting this region of the body. The Whipple operation is associated with a significant complication rate. Previous studies have shown that in a broad range of surgical procedures, using a reduced amount of intravenous fluids along with a special type of fluid called hypertonic saline during and after the procedure can lower complication rates associated with the heart and lungs during recovery from surgery. The purpose of this study is to determine if using a reduced amount of intravenous fluids as well as hypertonic saline (a salt concentrated form of intravenous fluids) during the Whipple operation and in the immediate period after surgery can reduce complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anastomotic Leak
Delayed Gastric Emptying
Myocardial Infarction
+2 more

Side effects data

From 2014 Phase 4 trial • 40 Patients • NCT01602692
40%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 3% salineExperimental Treatment1 Intervention
Patients will received 3% saline in conjunction with lactated ringers solution intra and post operatively for a net reduction in total fluid administration
Group II: Lactated RingersActive Control1 Intervention
15cc/kg/hr of lactated ringers solution intraoperatively

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,225 Total Patients Enrolled
Harish Lavu, MDPrincipal InvestigatorThomas Jefferson University
5 Previous Clinical Trials
1,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~19 spots leftby Apr 2025