Post-ERCP PancreatitisNCT04876768
Effects of High FIO2 on Post-ERCP Pancreatitis.
A study testing Use of different concentrations of oxygen during ERCP in people with Post-ERCP Pancreatitis, run by Syed Z. Ali, MD at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-ERCP Pancreatitis
- What is being tested?
- Use of different concentrations of oxygen during ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing ERCP
- 18 years and older
- capable of giving consent for the procedure
Who cannot join
- 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
Show all 10Show fewer
- Pancreatic malignancy
- ICU patients
- Patients on home oxygen at baseline.
- Incarcerated patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Intra-procedural Oxygen Fraction on Post-ERCP Pancreatitis: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Post-ERCP Pancreatitis
- Being tested
- Use of different concentrations of oxygen during ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of different concentrations of oxygen during ERCPProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: 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%. Receives: Procedure: Use of different concentrations of oxygen during ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months (90 minutes post-procedure to 2months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start18 May 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syed Z. Ali, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Syed Z. Ali, MD, University of Kentucky
- Investigators
- Moamen M. Gabr, MD, MSc, Principal investigator, Assistant Professor, Internal Medicine, Gastroenterology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876768
- Sponsor's protocol ID
- 56565
- Status last verified
- Nov 2022
- First submitted
- 3 May 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9684657Masci 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.
PubMed 11232684Andriulli 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.
PubMed 17509029Freeman 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.
PubMed 8782497Makela 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.
PubMed 9279965Gross 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.
PubMed 7509768Elmunzer 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.
PubMed 22494121Hovaguimian 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.
PubMed 23719611Testoni 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.
PubMed 20372116
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Intra-procedural Oxygen Fraction on Post-ERCP Pancreatitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04876768
- Acronym / sponsor ID
- 56565
- Conditions
- Post-ERCP Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Syed Z. Ali, MDUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of 80% oxygen(high oxygen fraction) during ERCP | Experimental | Procedure: Use of different concentrations of oxygen during ERCPAnesthetist 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%. |
| Use of 30% oxygen(normal oxygen fraction) during ERCP | Active comparator | Procedure: Use of different concentrations of oxygen during ERCPAnesthetist 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%. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients undergoing ERCP
- 18 years and older
- capable of giving consent for the procedure
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of different concentrations of oxygen during ERCPThe 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. | Procedure or surgery | Use of 30% oxygen(normal oxygen fraction) during ERCP, Use of 80% oxygen(high oxygen fraction) during ERCP |
Primary outcome
Percentage of Patients with Post ERCP Pancreatitis
Time frame: 2 months (90 minutes post-procedure to 2months follow-up)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 9684657Loperfido 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.
- Background: PubMed 11232684Masci 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.
- Background: PubMed 17509029Andriulli 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.
- Background: PubMed 8782497Freeman 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.
- Background: PubMed 9279965Makela 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.
- Background: PubMed 7509768Gross 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.
- Background: PubMed 22494121Elmunzer 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.
- Background: PubMed 23719611Hovaguimian 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.
- Background: PubMed 20372116Testoni 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.
- Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study.Link provided by the sponsor.
- Complications of diagnostic and therapeutic ERCP: a prospective multicenter study.Link provided by the sponsor.
- Incidence rates of post-ERCP complications: a systematic survey of prospective studiesLink provided by the sponsor.
- Complications of endoscopic biliary sphincterotomy.Link provided by the sponsor.
- Inhibition of serum phospholipase-A2 in acute pancreatitis by pharmacological agents in vitroLink provided by the sponsor.
- Inflammatory mediators and cytokines--new aspects of the pathophysiology and assessment of severity of acute pancreatitis?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moamen M. Gabr, MD, MSc principal investigator
Assistant Professor, Internal Medicine, Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of different concentrations of oxygen during ERCP in people with Post-ERCP Pancreatitis, run by Syed Z. Ali, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with Post ERCP Pancreatitis (time frame: 2 months (90 minutes post-procedure to 2months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04876768, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.