Optimal Time to Repeat Endoscopy following Primary or Secondary Prophylaxis of Esophageal Varices with Band Ligation: A Randomized, Prospective Trial

Study ID
STU 112010-107

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Clements University Hospital
  • Parkland Health & Hospital System

Contact
Rebecca Chason
214-590-6607
rebecca.chason@utsouthwestern.edu

Principal Investigator
Amit Singal

Summary

This is not a treatment study, however it is an interventional study as the study is directing the timing of a recommended procedure based on randomization. all procedures performed will be done as standard of care (i.e. upper endoscopy, blood draws, medication administration). This study will observe how quickly esophageal varices are being eradicated based on the randomization assignment.

The study will include patients with all-cause hepatic cirrhosis who present to our hospital with a variceal bleed requiring band ligation using current standard of care practice or patients with Child B or C cirrhosis who are referred to the Gi endoscopy lab for eV screening.

Patients who are unable to enroll in the study due to mental impairment due to hepatic enephelopathy will be consented via the subject's legal authorized representative (LaR). The LaR must be able and willing to understand, sign and date an informed consent document, and authorize access to protected health information on behalf of the subject. if a subject has difficulty understanding and is unable to provide consent due to the severity of their hepatic encephalopathy (altered mental status), an LaR must act on the subject's behalf and will be required to provide consent. The LaR should be a companion (defined as a spouse or significant other, children greater than 18 years old, first or second degree relative or friend that is familiar with everyday activities of the subject).

each patient will be treated using standard-of-care pharmacotherapy until and after endoscopy, including intravenous octreotide, proton pump inhibitor, and/or a non-selective beta blocker. Multiple patient characteristics will be recorded, including demographics, vital signs, cirrhosis etiology, pertinent physical exam findings related to stigmata of liver disease, history of varices and variceal bleeding, history of previous beta blocker and/or proton pump inhibitor use, hospitalization status (i.e. inpatient, outpatient, iCu) and presentation. Laboratory data will also be documented, including complete blood count, basic metabolic profile, liver function tests, aPRi, MeLD/Child-Pugh Score, and coagulation indices (aPRi [?] aspartate aminotransferase to platelet ratio index; MeLD [?] Mayo end-Stage Liver Disease). endoscopy related variables will be collected including stigmata of variceal bleeding present, number of bands placed, number and grade of esophageal varices, and time to endoscopy.

after banding ligation is performed, patients will be discharged after appropriate up-titration of beta blockers as well as initiation, up-titration or continuation of proton pump inhibitors where applicable, as per current standard of care. after enrolling in the study, subjects will be randomly assigned to follow up in our outpatient endoscopy lab at two varying intervals, at 10 +/- 3 days oR at 20 +/- 4 days. The study team including principal investigators will take the responsibility for scheduling follow up endoscopy according to randomization. upon return, a short questionnaire will be provided and repeat upper endoscopy will be performed. as stated in current guidelines, if eradication is not achieved, further bands will be placed, and the patient will be asked to return for repeat endoscopy at the previously randomized interval until eradication is achieved. once esophageal varices have been eradicated, a repeat endoscopy will be performed at 3 and 9 months, as per current guidelines and standard of care. The above mentioned endoscopy related variables will be collected at each endoscopic procedure.

Participant Eligibility

Patients aged 18 years or older with all causes of cirrhosis who present with a variceal bleed requiring EVBL and patients with Child's B or C cirrhosis who are referred to the GI endoscopy lab for EV screening.