Effects of High FIO2 on Post-ERCP Pancreatitis.

Summary

Post-ERCP pancreatitis is one of the most common complications accounting for substantial morbidity and mortality. The incidence of post-ERCP pancreatitis (PEP) has been studied in several large clinical trials and ranges from 1.6-15%. However most studies have demonstrated rates around 5%. This complication alone is estimated to cost the US healthcare around $150 million annually. To prevent this complication several pharmacological agents have been studied and no medication has been proved to be consistently effective in preventing this complications. Cyclo-oxygenase, and phospholipase A2 pathways are believed to play an important role in the pathogenesis of acute pancreatitis and so non-steroidal anti-inflammatory drugs (NSAIDs) have been extensively studied in the prevention of post-ERCP pancreatitis. One of the landmark studies done on prophylactic NSAIDs for PEP showed that rectal indomethacin significantly reduce the incidence of PEP (PEP developed in 9.2% vs. 16.9% of indomethacin and placebo groups respectively). Since then the use of rectal NSAIDs has become a standard chemo-prophylaxis for prevention of PEP especially in high risk patients. However, newly published meta-analysis showed that the role of peri-procedural rectal Indomethacin is doubtful in patients with average risk for PEP.

In this prospective randomized clinical study, we propose to study the effects of supplemental peri-operative oxygen on the incidence of PEP. The effects of high oxygen fraction (FIO2) has extensively been studied in reducing the incidence of surgical site infection, postoperative nausea, vomiting and to prevent postoperative atelectasis. Changing the FIO2 during a procedure can be a simple, inexpensive and low risk intervention to prevent post-procedure complications.

Conditions

• Post-ERCP Pancreatitis

Interventions

PROCEDURE

Use of different concentrations of oxygen during ERCP

The endoscopic intervention will be conducted in the endoscopy suite located at UK Albert B. Chandler Hospital in Lexington, Kentucky. ERCP/EUS uses an endoscope which is a long flexible narrow tube with a camera at the end is passed through the mouth, esophagus, stomach and the first part of the duodenum. The goal is to access a small elevation in the duodenum called the papilla of Vater. This papilla drains the biliary and pancreatic ducts which brings digestive juices from the liver, gallbladder and the pancreas. The endoscopist will inject contrast dye through the papilla into the ducts and takes X-rays to show lesions such as stones, strictures or blockages. If appropriate these can be treated by passing instruments through a port in the endoscope. Immediately following the endoscopic intervention; complications (bleeding, aspiration, perforation) will be recorded by study personnel as either yes or no, which will be used to assess the overall success of the procedure.

Sponsors & Collaborators

• Syed Z. Ali, MD

  lead OTHER

Principal Investigators

• Moamen M. Gabr, MD, MSc · Assistant Professor, Internal Medicine, Gastroenterology

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-18

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• United States

Study Locations