Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin
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| ClinicalTrials.gov Identifier: NCT03057769 |
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Recruitment Status :
Terminated
(This study was terminated because of an interim analysis suggesting futility of papillary epinephrine spraying in PEP prevention.)
First Posted : February 20, 2017
Last Update Posted : October 27, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatitis Endoscopic Retrograde Cholangiopancreatography | Drug: Papillary epinephrine spraying Drug: Papillary saline spraying Drug: Indomethacin | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Papillary Epinephrine Spraying on Post-ERCP Pancreatitis in Patients Received Rectal Indomethacin: A Multi-center, Double-blind, Randomized Controlled Trial |
| Actual Study Start Date : | February 1, 2017 |
| Actual Primary Completion Date : | October 26, 2017 |
| Actual Study Completion Date : | October 26, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PES group
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.
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Drug: Papillary epinephrine spraying
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.
Other Name: PES Drug: Indomethacin All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP. |
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Placebo Comparator: Control group
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.
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Drug: Papillary saline spraying
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.
Other Name: Control Drug: Indomethacin All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP. |
- Overall post-ERCP pancreatitis (PEP) [ Time Frame: 30 days ]
- Moderate to severe PEP [ Time Frame: 30 days ]
- Clinical significant gastrointestinal bleeding [ Time Frame: 30 days ]
- Overall ERCP complications [ Time Frame: 30 days ]
- Severity of PEP evaluated by updated Atlanta criteria [ Time Frame: 30 days ]
- ERCP-related perforation [ Time Frame: 30 days ]
- Biliary infection [ Time Frame: 30 days ]
- Length of post-procedure hospital stay [ Time Frame: 30 days ]
- Death [ Time Frame: 30 days ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-80 years old patients planned for ERCP.
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057769
| China, Fujian | |
| Department of Gastroenterology, Successful Hospital of Xiamen university | |
| Xiamen, Fujian, China, 361000 | |
| Department of Gastroenterology, Zhongshan Hospital of Xiamen university | |
| Xiamen, Fujian, China, 361004 | |
| China, Gansu | |
| Department of General Surgery, The First Hospital of Lanzhou University | |
| Lanzhou, Gansu, China, 730000 | |
| China, Shaanxi | |
| Endoscopy Center, Ankang Central Hospital | |
| Ankang, Shaanxi, China, 725000 | |
| Xijing Hospital of Digestive Diseases | |
| Xi'an, Shaanxi, China, 710032 | |
| Department of Gastroenterology, No. 451 Hospital | |
| Xi'an, Shaanxi, China, 710068 | |
| China, Xinjiang | |
| Department of Gastroenterology, The First Affiliated Hospital of the Medical College, Shihezi University | |
| Shihezi, Xinjiang, China, 832008 | |
| Department of Gastroenterology, Urumqi General Hospital of Lanzhou Military Region | |
| Urumqi, Xinjiang, China, 830000 | |
| China, Zhejiang | |
| Department of Gastroenterology, Hangzhou First People's Hospital | |
| Hangzhou, Zhejiang, China, 310006 | |
| China | |
| Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University | |
| Yinchuan, China, 750004 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Yanglin Pan, Associate professor, Air Force Military Medical University, China |
| ClinicalTrials.gov Identifier: | NCT03057769 |
| Other Study ID Numbers: |
KY20162097-1 |
| First Posted: | February 20, 2017 Key Record Dates |
| Last Update Posted: | October 27, 2017 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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ERCP, post-ERCP pancreatitis, indomethacin, epinephrine |
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Pancreatitis Pancreatic Diseases Digestive System Diseases Indomethacin Epinephrine Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Anti-Inflammatory Agents Antirheumatic Agents Gout Suppressants Tocolytic Agents Reproductive Control Agents Cyclooxygenase Inhibitors |