Effects of High FIO2 on Post-ERCP Pancreatitis.
Condition: Post-ERCP Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional

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.
    

Detailed description: 
      The study will be a prospective, parallel-group, randomized double blinded control study
      conducted at University of Kentucky - Chandler Medical Center. Both the patient and the
      endoscopist will be blinded to the group assignment. Permuted block randomization will be
      used to randomly allocate a participant to a treatment group that will maintain a balance
      across treatment groups. Each block will have a specified number of randomly ordered
      treatment assignments. To assure randomization is blinded, randomization lists will be
      produced by the statistical team using varying block sizes of 100. Group assignments will be
      kept in sealed, sequentially numbered envelopes until used. Once patient is determined to be
      eligible, endoscopist will obtain consent and anesthetist will open the envelope which will
      assign patients either to Group 1: 30% FIO2 or Group 2: 80% FIO2. An anesthesia provider will
      administer FIO2 to the patient throughout the procedure period. Additional supplemental
      oxygen will be given to patients in either group at any time, as necessary, to maintain
      oxygen saturation as measured by pulse oximeter > 92%. Patients will be observed in the
      recovery area for at least 90 minutes after the procedure. Patients who develop abdominal
      pain during the post-endoscopy period are admitted to the hospital and standard pancreatitis
      clinical care is provided. Patients who are discharged after an uneventful ERCP will be
      contacted by telephone within 5 days to capture delayed occurrence of pancreatitis. Patients
      will again be contacted at 30 days to assess for delayed adverse events and to determine the
      severity of post-ERCP pancreatitis, which is defined in part by the length of hospitalization
      for pancreatitis.

      Patients who do not consent to be included in the study will receive the standard endoscopic
      treatment at the discretion of the therapeutic endoscopist. The endoscopic intervention will
      be conducted in the endoscopy suite on the third floor at the University of Kentucky
      Healthcare medical center in Lexington, Kentucky. If no additional endoscopic intervention is
      required, then the patient will be scheduled for subsequent follow up clinic visits. After
      the conclusion of the study, patients will continue to be followed as clinically necessary by
      either the same or another gastroenterologist.

      The patient has the right to withdraw consent to participate in the study at any time. The
      patient can be withdrawn from the study if they are not able to follow directions for study
      participation. If the patient decides to no longer take part in the study, their decision
      will have no effect on the medical care they will receive.
    

Intervention name(s): Use of different concentrations of oxygen during ERCP
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention