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| ID | Type | Description | Link |
|---|---|---|---|
| 20131106-7 | Other Identifier | Ethics committee of Xijing Hospital |
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Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-ERCP group | Experimental | Pre-ERCP rectal Indomethacin in all patients. |
|
| Post-ERCP group | Active Comparator | Post-ERCP rectal Indomethacin in high-risk patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-ERCP rectal Indomethacin | Drug | Rectal Indomethacin was administrated within 30min before ERCP in all patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-ERCP Pancreatitis | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate-to-severe Pancreatitis | Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery). | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanglin Pan, M.D. | Xijing Hospital of Digestive Diseases.The Fourth Military Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | 730000 | China | ||
| General Hospital of NingXia Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23164513 | Result | 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. | |
| 22494121 | Result | 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. |
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After screening, 2725 patients were excluded: 193 did not meet inclusion criteria, 2304 met exclusion criteria and 228 patients declined to participate.
From Dec 15, 2013 to Sep 21, 2015, 5325 consecutive patients undergoing ERCP in six centers in China were considered for the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-ERCP Group | Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients. |
| FG001 | Post-ERCP Group | Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-ERCP Group | Pre-ERCP rectal Indomethacin in all patients. Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients. |
| BG001 | Post-ERCP Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-ERCP Pancreatitis | Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights. | Posted | Number | participants | 30 days |
|
30 days
Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-ERCP Group | Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate to severe bleeding | Gastrointestinal disorders | Bleeding | Systematic Assessment | Moderate to severe bleeding was defined as clinically significant bleeding with hemoglobin level drop ≥3g with the need for transfusion, angiographic intervention or surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild bleeding | Gastrointestinal disorders | Mild bleeding | Systematic Assessment | Clinical evidence of bleeding (ie, not just endoscopic); Hb level drop <3 g; no need for transfusion. |
Firstly, patients could not be blinded to the treatment assignment. Secondly, it remains unclear if patients with prior EST will benefit from rectal indomethacin. Thirdly, the findings need to be validated in different clinical settings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hui Luo | Xijing hospital of digestive diseases | 862984771536 | fmmulh@163.com |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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| Post-operational Rectal Indomethacin | Drug | Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not. |
|
| Yinchuan |
| Ningxia |
| 750004 |
| China |
| Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | 710032 | China |
| No. 451 Hospital | Xi'an | Shaanxi | 710054 | China |
| The First Affiliated Hospital Of Xi'an Jiaotong University | Xi'an | Shaanxi | 710061 | China |
| Urumqi General Hospital of Lanzhou Military Region | Ürümqi | Xinjiang | 830002 | China |
| 27133971 | Derived | 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. |
Post-ERCP rectal Indomethacin in high-risk patients.
Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| High-risk patients | met at least one of the major criteria - clinical suspicion of sphincter of Oddi dysfunction, a history of PEP, pancreatic sphincterotomy, precut sphincterotomy, ≥8 cannulation attempts, pneumatic dilatation of an intact biliary sphincter, or ampullectomy. or met two or more of the minor criteria - age<50 and female gender, a history of recurrent pancreatitis (≥2 episodes), ≥3 injections of contrast into the pancreatic duct with ≥1 injection to the tail of the pancreas, opacification of pancreatic acini, or brush cytology performed on the pancreatic duct. | Number | participants |
|
|
|
| Secondary | Moderate-to-severe Pancreatitis | Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery). | Posted | Number | participants | 30 days |
|
|
|
| 15 |
| 1,297 |
| 26 |
| 1,297 |
| EG001 | Post-ERCP Group | Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not. | 15 | 1,303 | 33 | 1,303 |
|
| Moderate to severe biliary infection | Infections and infestations | Biliary infection | Systematic Assessment | Febrile or septic illness requiring >3 d of hospital treatment or need endoscopic or percutaneous intervention. Septic shock or surgery. |
|
|
| Mild biliary infection | Infections and infestations | Miliary infection | Systematic Assessment | Mild biliary infection was defined as a temperature of more than 38°C for 24-48 h after the procedure, thought to have a biliary cause (colicky pain and cholestasis/jaundice) without evidence of other concomitant infections. |
|
| Mild perforation | Gastrointestinal disorders | Mild perforation | Systematic Assessment | Possible, or only very slight leak of fluid or contrast dye; treatable by fluids and suction for ≤3d |
|
| Pulmonary infection | Infections and infestations | Pulmonary infection | Systematic Assessment |
|
| Incomplete bowel obstruction | Gastrointestinal disorders | Incomplete bowel obs | Systematic Assessment |
|
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