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Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac

Primary Purpose

Post-ERCP Acute Pancreatitis, NSAIDs, Indomethacin

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
100mg diclofenac
100mg indomethacin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-90 years old patients planned to undergo ERCP Exclusion Criteria: Allergy to NSAIDs The administration of NSAIDs within 7 days Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure) Previous biliary sphincterotomy and papillary large balloon dilation Acute pancreatitis within 3 days before ERCP Hemodynamical instability Pregnancy or lactation Unable to give informed consent

Sites / Locations

  • Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • Department of Gastroenterology, Fujian Medical University Xiamen Humanity HospitalRecruiting
  • Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support ForceRecruiting
  • Department of Gastroenterology, Huaihe Hospital of Henan UniversityRecruiting
  • Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical UniversityRecruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Department of Gastroenterology,The 986th Hospital of Xijing HospitalRecruiting
  • Xijing Hospital of Digestive Diseases, Air Force Military Medical University, ChinaRecruiting
  • Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong UniversityRecruiting
  • Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical UniversityRecruiting
  • Department of Gastroenterology, General Hospital of Xinjiang Military RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

diclofenac group

Indomethacin group

Arm Description

Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.

Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure.

Outcomes

Primary Outcome Measures

Rate of post-ERCP Pancreatitis
The diagnosis of post-ERCP pancreatitis was confirmed if there was new onset of upper abdominal pain associated with an increased amylase or lipase level of at least 3 times the upper limit of normal range at 24 hours after ERCP, accompanied with extension of hospitalization for at least 2 nights.

Secondary Outcome Measures

Rate of moderate or severe PEP
The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Rate of Overall ERCP-related complications
ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Rate of NSAIDs-related complications
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death

Full Information

First Posted
June 20, 2023
Last Updated
July 7, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT05947461
Brief Title
Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac
Official Title
Rectal Disclofenac Versus Indomethacin for Prevention of Post-ERCP Pancreatitis (DIPPP): A Multicentre, Double-blind, Randomised, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-ERCP pancreatitis (PEP) is the most common complication after ERCP, which was associated with occasional mortality, prolonged hospital days and increased health costs. Some studies investigated the effectiveness of different Nonsteroidal antiinflammatory drugs (NSAIDs) for prevent PEP. However, several high-quality RCTs and meta-analyses consistently demonstrated only100mg rectal indomethacin or diclofenac significantly reduced PEP incidence compared with placebos. Thus, European Society of Gastrointestinal Endoscopy, American Society for Gastrointestinal Endoscopy and Japanese Society of Hepato-Biliary-Pancreatic surgery guidelines recommended rountine administration of 100mg rectal indomethacin or diclofenac in unselected patients who underwent ERCP. Up to date, the mechanisms of NSAIDs in preventing pancreatitis were not fully elucidated. Diclofenac and Indomethacin showed similar inhibitory effects in phospholipase A2 and cyclooxygenase pathways. And the peak concentration of diclofenac and indomethacin both occurs between 30 and 90 min after rectal administration. However, diclofenac may be a stronger inhibitor of other pancreatitis-related imflammatory siginals (e.g. nuclear factor kappa-B) than indomethacin. Recently, several meta-analyses found 100mg rectal diclofenac to be more efficacious than 100mg rectal indomethacin. Despite these data, there is no conclusive evidence to prove that rectal diclofenac could provide incremental benefits over indomethacin from high-quality randomized, controlled trials. Therefore, the investigators conducted a multicenter, double-blind, randomized, controlled clinical trial to evaluate the efficacy of rectal diclofenac versus indomethacin for the prevention of post-ERCP pancreatitis in average-risk patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis, NSAIDs, Indomethacin, Diclofenac, Endoscopic Retrograde Cholangiopancreatography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants in the interventional group received 100mg rectal dicfenac
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
diclofenac group
Arm Type
Experimental
Arm Description
Patients without contraindications in diclofenac group received 100mg rectal diclofenac 30 mins before ERCP procedure.
Arm Title
Indomethacin group
Arm Type
Active Comparator
Arm Description
Patients without contraindications in indomethacin group received 100mg rectal indomethacin 30 mins before ERCP procedure.
Intervention Type
Drug
Intervention Name(s)
100mg diclofenac
Intervention Description
All patients without contraindications should receive 100mg rectal diclofenac 30mins before ERCP procedure
Intervention Type
Drug
Intervention Name(s)
100mg indomethacin
Intervention Description
All patients without contraindications should receive 100mg rectal indomethacin 30mins before ERCP procedure
Primary Outcome Measure Information:
Title
Rate of post-ERCP Pancreatitis
Description
The diagnosis of post-ERCP pancreatitis was confirmed if there was new onset of upper abdominal pain associated with an increased amylase or lipase level of at least 3 times the upper limit of normal range at 24 hours after ERCP, accompanied with extension of hospitalization for at least 2 nights.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of moderate or severe PEP
Description
The severity classification of post-ERCP pancreatitis was defined according to the Cotton Criteria. Mild PEP: with an extension of hospitalization period of 2-3 days; Moderate PEP: with an extension of hospitalization period of 4-10 days; Severe PEP: with an extension of more than 10 days, or hemorrhagic pancreatitis, phlegmon, or pseudocyst, intervention (percutaneous drainage or surgery), or death.
Time Frame
30 days
Title
Rate of Overall ERCP-related complications
Description
ERCP-related complications include post-ERCP pancreatitis, gastrointestinal bleeding, perforation or infection according to Cotton Criteria.
Time Frame
30 days
Title
Rate of patients with different severity of pancreatitis evaluated by revised Atlanta criteria
Time Frame
30 days
Title
Rate of NSAIDs-related complications
Description
NSAIDs-related complications include: acute kidney injury, allergic reaction, gastrointestinal bleeding, myocardial infarction, cerebrovascular accident, and death
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Rate of ERCP-related perforation
Description
Perforation was established according to Cotton criteria
Time Frame
30 days
Title
Rate of ERCP-related infection
Description
Infection was established according to Cotton criteria
Time Frame
30 days
Title
Rate of ERCP-related bleeding
Description
Bleeding was established according to Cotton criteria
Time Frame
30 days
Title
Rate of mortality
Time Frame
30 days
Title
Number of hospital days after ERCP
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-90 years old patients planned to undergo ERCP Exclusion Criteria: Allergy to NSAIDs The administration of NSAIDs within 7 days Not suitable for NSAIDs administration (gastrointestinal hemorrhage within 4 weeks, renal dysfunction [Cr >1.4mg/dl=120umol/l]; presence of coagulopathy before the procedure) Previous biliary sphincterotomy and papillary large balloon dilation Acute pancreatitis within 3 days before ERCP Hemodynamical instability Pregnancy or lactation Unable to give informed consent
Facility Information:
Facility Name
Department of gastroenterology, Second Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Ning, M.D.
Phone
+8613996476336
Email
ningbo.bo@163.com
First Name & Middle Initial & Last Name & Degree
Bo Ning, M.D.
Facility Name
Department of Gastroenterology, Fujian Medical University Xiamen Humanity Hospital
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongchun Zhang
Phone
+8613720892152
Email
Zrc.700502@163.com
Facility Name
Department of Gastroenterology, The 980th Hospital of the PLA Joint Logistics Support Force
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haifeng Jin
Phone
8618503240205
Email
jinhfhfjin@163.com
Facility Name
Department of Gastroenterology, Huaihe Hospital of Henan University
City
Kaifeng
State/Province
Henan
ZIP/Postal Code
475000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianghai Zhao, MD
Phone
+8615191903630
Email
493109907@qq.com
Facility Name
Department of Hepatobiliary Surgery, General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qi Wang, M.D.
Phone
+8613895098592
Email
wq-6562@163.com
First Name & Middle Initial & Last Name & Degree
Genwang Wang, M.D.
Phone
+8613895689237
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Zhao, MD
Phone
8613468883265
Email
zhaogang799@126.com
Facility Name
Department of Gastroenterology,The 986th Hospital of Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Wang, M.D.
Phone
29771536
Email
fmmulh@163.com
Facility Name
Xijing Hospital of Digestive Diseases, Air Force Military Medical University, China
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanglin Pan, MD
Phone
13991811225
Email
yanglinpan@hotmail.com
Facility Name
Deparment of hepatobiliary surgery, The First Affiliated Hospital Of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Sun, MD
Phone
86-29-85323905
Email
sunhaoxjyf@126.com
Facility Name
Department of Gastroenterology and Endoscopy, Department of Gastroenterology and EndoscopyThe Third Affiliated Hospital of Naval Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingxing Xia
Phone
+8617612171231
Email
1063990579@qq.com
Facility Name
Department of Gastroenterology, General Hospital of Xinjiang Military Region
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanguo Nie
Phone
+8613999116558
Email
niezg@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Yun You
Phone
+8613565865240
First Name & Middle Initial & Last Name & Degree
Jinshan Sun

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
2070995
Citation
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Results Reference
result
PubMed Identifier
23100216
Citation
Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
Results Reference
result
PubMed Identifier
35941494
Citation
Kang X, Guo X, Chen Z, Zhou Z, Luo H, Lu Y, Lou L, Guo X, Pan Y. The Incidence and Severity of Post-ERCP Pancreatitis in Patients Receiving Standard Administration of NSAIDs: a Systematic Review and Meta-analysis. J Gastrointest Surg. 2022 Nov;26(11):2380-2389. doi: 10.1007/s11605-022-05399-6. Epub 2022 Aug 8.
Results Reference
result
PubMed Identifier
34214449
Citation
Akshintala VS, Sperna Weiland CJ, Bhullar FA, Kamal A, Kanthasamy K, Kuo A, Tomasetti C, Gurakar M, Drenth JPH, Yadav D, Elmunzer BJ, Reddy DN, Goenka MK, Kochhar R, Kalloo AN, Khashab MA, van Geenen EJM, Singh VK. Non-steroidal anti-inflammatory drugs, intravenous fluids, pancreatic stents, or their combinations for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: a systematic review and network meta-analysis. Lancet Gastroenterol Hepatol. 2021 Sep;6(9):733-742. doi: 10.1016/S2468-1253(21)00170-9. Epub 2021 Jun 30.
Results Reference
result
PubMed Identifier
27133971
Citation
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.
Results Reference
result

Learn more about this trial

Prevention of Post-ERCP Pancreatitis by Indomethacin vs Diclofenac

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