Effects of High FIO2 on Post-ERCP Pancreatitis.

NCT04876768 | Completed

• 1 other identifier: 56565
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients with Post ERCP Pancreatitis

  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 will be 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. The patient participation in this study, which includes the endoscopy procedures and follow-up may last up to 2 months.

  2 months (90 minutes post-procedure to 2months follow-up)

Study Arms (2)

Use of 80% oxygen(high oxygen fraction) during ERCP

EXPERIMENTAL

Anesthetist will open the envelope of randomly assigned groups which will assign patients to 80% FIO2(supplemental perioperative high oxygen fraction). 80% FIO2 will be maintained during the ERCP procedure. Maintaining oxygen saturation of \> 92% through administration of oxygen via nasal cannula, mask or ventilator will be per anesthetist discretion. Additional supplemental oxygen will be given to patients at any time, as necessary, to maintain oxygen saturation as measured by pulse oximeter \> 92%.

Procedure: Use of different concentrations of oxygen during ERCP

Use of 30% oxygen(normal oxygen fraction) during ERCP

ACTIVE COMPARATOR

Anesthetist will open the envelope of randomly assigned groups which will assign patients to 30% FIO2 (normal oxygen fraction). 30% FIO2 will be maintained during the ERCP procedure. Maintaining oxygen saturation of \> 92% through administration of oxygen via nasal cannula, mask or ventilator will be per anesthetist discretion. Additional supplemental oxygen will be given to patients at any time, as necessary, to maintain oxygen saturation as measured by pulse oximeter \> 92%.

Procedure: Use of different concentrations of oxygen during ERCP

Interventions

Use of different concentrations of oxygen during ERCP PROCEDURE

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.

Use of 30% oxygen(normal oxygen fraction) during ERCP; Use of 80% oxygen(high oxygen fraction) during ERCP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing ERCP
• years and older
• capable of giving consent for the procedure

You may not qualify if:

• Unwillingness or inability to consent for the study
• Age less than 18 years
• Standard contraindications to ERCP
• Acute pancreatitis within 72hrs prior to ERCP
• Chronic calcific pancreatitis
• Pancreatic divisum
• Pancreatic malignancy
• ICU patients
• Patients on home oxygen at baseline.
• Incarcerated patients.

Sponsors & Collaborators

• Syed Z. Ali, MD: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (9)

• Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. doi: 10.1016/s0016-5107(98)70121-x.

  PMID: 9684657 BACKGROUND

• Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, Minoli G, Crosta C, Comin U, Fertitta A, Prada A, Passoni GR, Testoni PA. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol. 2001 Feb;96(2):417-23. doi: 10.1111/j.1572-0241.2001.03594.x.

  PMID: 11232684 BACKGROUND

• Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.

  PMID: 17509029 BACKGROUND

• Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.

  PMID: 8782497 BACKGROUND

• Makela A, Kuusi T, Schroder T. Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro. Scand J Clin Lab Invest. 1997 Aug;57(5):401-7. doi: 10.3109/00365519709084587.

  PMID: 9279965 BACKGROUND

• Gross V, Leser HG, Heinisch A, Scholmerich J. Inflammatory mediators and cytokines--new aspects of the pathophysiology and assessment of severity of acute pancreatitis? Hepatogastroenterology. 1993 Dec;40(6):522-30.

  PMID: 7509768 BACKGROUND

• Elmunzer BJ, Scheiman JM, Lehman GA, Chak A, Mosler P, Higgins PD, Hayward RA, Romagnuolo J, Elta GH, Sherman S, Waljee AK, Repaka A, Atkinson MR, Cote GA, Kwon RS, McHenry L, Piraka CR, Wamsteker EJ, Watkins JL, Korsnes SJ, Schmidt SE, Turner SM, Nicholson S, Fogel EL; U.S. Cooperative for Outcomes Research in Endoscopy (USCORE). A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis. N Engl J Med. 2012 Apr 12;366(15):1414-22. doi: 10.1056/NEJMoa1111103.

  PMID: 22494121 BACKGROUND

• Hovaguimian F, Lysakowski C, Elia N, Tramer MR. Effect of intraoperative high inspired oxygen fraction on surgical site infection, postoperative nausea and vomiting, and pulmonary function: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2013 Aug;119(2):303-16. doi: 10.1097/ALN.0b013e31829aaff4.

  PMID: 23719611 BACKGROUND

• Testoni PA, Mariani A, Giussani A, Vailati C, Masci E, Macarri G, Ghezzo L, Familiari L, Giardullo N, Mutignani M, Lombardi G, Talamini G, Spadaccini A, Briglia R, Piazzi L; SEIFRED Group. Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study. Am J Gastroenterol. 2010 Aug;105(8):1753-61. doi: 10.1038/ajg.2010.136. Epub 2010 Apr 6.

  PMID: 20372116 BACKGROUND

Related Links

• Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.
• Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.
• Incidence rates of post-ERCP complications: a systematic survey of prospective studies
• Complications of endoscopic biliary sphincterotomy.
• Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitro
• Inflammatory mediators and cytokines--new aspects of the pathophysiology and assessment of severity of acute pancreatitis?
• A randomized trial of rectal indomethacin to prevent post-ERCP pancreatitis.
• Effect of intraoperative high inspired oxygen fraction on surgical site infection, postoperative nausea and vomiting, and pulmonary function: systematic review and meta-analysis of randomized controlled trials.
• Risk factors for post-ERCP pancreatitis in high- and low-volume centers and among expert and non-expert operators: a prospective multicenter study.

Study Officials

• Moamen M. Gabr, MD, MSc

  Assistant Professor, Internal Medicine, Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Endoscopist will be blinded but the anesthetist will not.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: May 18, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)