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PancreatitisNCT03057769

Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin

A study testing Papillary epinephrine spraying, Papillary saline spraying and Indomethacin in people with Pancreatitis and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 10 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. It accounts for substantial morbidity and represents a substantial cost to health-care systems. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Papillary epinephrine spraying, Papillary saline spraying and Indomethacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,300 participants
Where
10 sitesChina
Study dates
1 Feb 2017to 26 Oct 2017
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old patients planned for ERCP.

Who cannot join

  • contraindications to ERCP
  • allergy to epinephrine or NSAIDs
  • Not suitable for pre-ERCP indomethacin (received NSAIDs within 7 days before the procedure; gastrointestinal hemorrhage within 4 weeks; renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure)
  • previous biliary sphincterotomy without planned pancreatic duct manipulation
  • ERCP for biliary stent removal or exchange without planned pancreatic duct manipulation
  • acute pancreatitis within 3 days before the procedure
  • unwilling or inability to provide consent
  • pregnant or breastfeeding women

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Endoscopy Center, Ankang Central Hospital

    Ankang, Shaanxi, 725000

  • Department of Gastroenterology, Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • Department of General Surgery, The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University

    Shihezi, Xinjiang, 832008

  • Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region

    Ürümqi, Xinjiang, 830000

  • Xijing Hospital of Digestive Diseases

    Xi'an, Shaanxi, 710032

  • Department of Gastroenterology, No. 451 Hospital

    Xi'an, Shaanxi, 710068

  • Department of Gastroenterology, Successful Hospital of Xiamen university

    Xiamen, Fujian, 361000

  • Department of Gastroenterology, Zhongshan Hospital of Xiamen university

    Xiamen, Fujian, 361004

  • Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University

    Yinchuan, 750004

Other trials in China

About this study

Official title: Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial

Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. It accounts for substantial morbidity and represents a substantial cost to health-care systems. European Society of Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines and recently large-scale RCT recommended routine use of NSAIDs indomethacin rectally before ERCP. Nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to inhibit prostaglandin synthesis, phospholipase A2 activity, and neutrophil/endothelial cell attachment, which is believed to play a key role in the pathogenesis of acute pancreatitis.

Other possible mechanisms have been suggested in the occurrence of pancreatitis. Papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. A meta-analysis (including 2 existing RCTs and post-hoc analysis of our previous study) of papillary epinephrine spraying compared with saline spraying or no intervention indicates a potential relative risk reduction of PEP (RR 0.34, 95%CI 0.19-0.61). Papillary epinephrine spraying may be an inexpensive and convenient alternative for prevention of post-ERCP pancreatitis. A large pragmatic RCT to determine whether routine using papillary epinephrine spraying can reduce post-ERCP pancreatitis is needed.

Being tested
Papillary epinephrine spraying, Papillary saline spraying, Indomethacin
Keywords
ERCP, post-ERCP pancreatitis, indomethacin, epinephrine
Medical subject headings
Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Papillary epinephrine sprayingDrug

    Also called PES

    All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.

  • Papillary saline sprayingDrug

    Also called Control

    All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.

  • IndomethacinDrug

    All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.

Study groups in NCT03057769
Study groupRoleWhat they receive
PES groupExperimentalAll patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.
Receives: Drug: Papillary epinephrine spraying; Drug: Indomethacin
Control groupPlacebo comparatorAll patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.
Receives: Drug: Papillary saline spraying; Drug: Indomethacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall post-ERCP pancreatitis (PEP)

    Measured: 30 days

Secondary outcomes (3)

  1. Moderate to severe PEP

    Measured: 30 days

  2. Clinical significant gastrointestinal bleeding

    Measured: 30 days

  3. Overall ERCP complications

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2017
  2. Study start1 Feb 2017
  3. Primary completion26 Oct 2017
  4. Study completion26 Oct 2017

Why it stopped: This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057769
Sponsor's protocol ID
KY20162097-1
Status last verified
Oct 2017
First submitted
15 Feb 2017
Last updated
27 Oct 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.

    PubMed 15173799

  • Dumonceau JM, Andriulli A, Elmunzer BJ, Mariani A, Meister T, Deviere J, Marek T, Baron TH, Hassan C, Testoni PA, Kapral C; European Society of Gastrointestinal Endoscopy. Prophylaxis of post-ERCP pancreatitis: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - updated June 2014. Endoscopy. 2014 Sep;46(9):799-815. doi: 10.1055/s-0034-1377875. Epub 2014 Aug 22.

    PubMed 25148137

  • Yokoe M, Takada T, Mayumi T, Yoshida M, Isaji S, Wada K, Itoi T, Sata N, Gabata T, Igarashi H, Kataoka K, Hirota M, Kadoya M, Kitamura N, Kimura Y, Kiriyama S, Shirai K, Hattori T, Takeda K, Takeyama Y, Hirota M, Sekimoto M, Shikata S, Arata S, Hirata K. Japanese guidelines for the management of acute pancreatitis: Japanese Guidelines 2015. J Hepatobiliary Pancreat Sci. 2015 Jun;22(6):405-32. doi: 10.1002/jhbp.259. Epub 2015 May 13.

    PubMed 25973947

  • Luo H, Zhao L, Leung J, Zhang R, Liu Z, Wang X, Wang B, Nie Z, Lei T, Li X, Zhou W, Zhang L, Wang Q, Li M, Zhou Y, Liu Q, Sun H, Wang Z, Liang S, Guo X, Tao Q, Wu K, Pan Y, Guo X, Fan D. Routine pre-procedural rectal indometacin versus selective post-procedural rectal indometacin to prevent pancreatitis in patients undergoing endoscopic retrograde cholangiopancreatography: a multicentre, single-blinded, randomised controlled trial. Lancet. 2016 Jun 4;387(10035):2293-2301. doi: 10.1016/S0140-6736(16)30310-5. Epub 2016 Apr 28.

    PubMed 27133971

  • Ding X, Chen M, Huang S, Zhang S, Zou X. Nonsteroidal anti-inflammatory drugs for prevention of post-ERCP pancreatitis: a meta-analysis. Gastrointest Endosc. 2012 Dec;76(6):1152-9. doi: 10.1016/j.gie.2012.08.021.

    PubMed 23164513

  • Matsushita M, Takakuwa H, Shimeno N, Uchida K, Nishio A, Okazaki K. Epinephrine sprayed on the papilla for prevention of post-ERCP pancreatitis. J Gastroenterol. 2009;44(1):71-5. doi: 10.1007/s00535-008-2272-8. Epub 2009 Jan 22.

    PubMed 19159075

  • Tarnasky P, Cunningham J, Cotton P, Hoffman B, Palesch Y, Freeman J, Curry N, Hawes R. Pancreatic sphincter hypertension increases the risk of post-ERCP pancreatitis. Endoscopy. 1997 May;29(4):252-7. doi: 10.1055/s-2007-1004185.

    PubMed 9255527

  • Johnson GK, Geenen JE, Johanson JF, Sherman S, Hogan WJ, Cass O. Evaluation of post-ERCP pancreatitis: potential causes noted during controlled study of differing contrast media. Midwest Pancreaticobiliary Study Group. Gastrointest Endosc. 1997 Sep;46(3):217-22. doi: 10.1016/s0016-5107(97)70089-0.

    PubMed 9378207

  • Ohno T, Katori M, Nishiyama K, Saigenji K. Direct observation of microcirculation of the basal region of rat gastric mucosa. J Gastroenterol. 1995 Oct;30(5):557-64. doi: 10.1007/BF02367779.

    PubMed 8574325

  • Xu LH, Qian JB, Gu LG, Qiu JW, Ge ZM, Lu F, Wang YM, Li YM, Lu HS. Prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis by epinephrine sprayed on the papilla. J Gastroenterol Hepatol. 2011 Jul;26(7):1139-44. doi: 10.1111/j.1440-1746.2011.06718.x.

    PubMed 21392105

  • Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.

    PubMed 27299638

  • Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30.

    PubMed 23896955

  • Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063.

    PubMed 24054878

  • Luo H, Wang X, Zhang R, Liang S, Kang X, Zhang X, Lou Q, Xiong K, Yang J, Si L, Liu W, Liu Y, Zhou Y, Wang S, Yang M, Chen W, Han Y, Shang G, Yang X, He Y, Zou Q, Guo W, Dai Y, Zeng W, Zhu X, Gong R, Li X, Nie Z, Wang Q, Wang L, Pan Y, Guo X, Fan D. Rectal Indomethacin and Spraying of Duodenal Papilla With Epinephrine Increases Risk of Pancreatitis Following Endoscopic Retrograde Cholangiopancreatography. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1597-1606.e5. doi: 10.1016/j.cgh.2018.10.043. Epub 2018 Oct 31.

    PubMed 30391434

Questions about this trial

What is this clinical trial studying?

A study testing Papillary epinephrine spraying, Papillary saline spraying and Indomethacin in people with Pancreatitis and Endoscopic Retrograde Cholangiopancreatography, run by Air Force Military Medical University, China at 10 sites in China.

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 1 inclusion and 8 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: stopped early, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.). Results are not available in the source record.

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?

Overall post-ERCP pancreatitis (PEP) (time frame: 30 days). 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 NCT03057769, which also lists 14 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 27 Oct 2017.

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