NCT02002650

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 27, 2016

Completed
Last Updated

June 29, 2016

Status Verified

May 1, 2016

Enrollment Period

1.9 years

First QC Date

December 1, 2013

Results QC Date

April 17, 2016

Last Update Submit

May 27, 2016

Conditions

Post-ERCP Acute Pancreatitis

Keywords

Indomethacin, pancreatitis, ERCP

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Moderate-to-severe Pancreatitis

    30 days

Study Arms (2)

Pre-ERCP group

EXPERIMENTAL

Pre-ERCP rectal Indomethacin in all patients.

Drug: Pre-ERCP rectal Indomethacin

Post-ERCP group

ACTIVE COMPARATOR

Post-ERCP rectal Indomethacin in high-risk patients.

Drug: Post-operational Rectal Indomethacin

Interventions

Pre-ERCP rectal IndomethacinDRUG

Rectal Indomethacin was administrated within 30min before ERCP in all patients.

Pre-ERCP group
Post-operational Rectal IndomethacinDRUG

Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Post-ERCP group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing diagnostic or therapeutic ERCP.

You may not qualify if:

  • Unwillingness or inability to consent for the study;
  • Age \< 18 years old;
  • Intrauterine pregnancy;
  • Breastfeeding mother;
  • Standard contraindications to ERCP;
  • Allergy to NSAIDs;
  • Received NSAIDs in prior 7 days;
  • Renal failure (Cr \>1.4mg/dl=120umol/l);
  • Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
  • Acute pancreatitis within 72 hours;
  • Known pancreatic head mass;
  • Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
  • ERCP for biliary stent removal or exchange without anticipated pancreatogram;
  • Known active cardiovascular or cerebrovascular disease.
  • Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

General Hospital of NingXia Medical University

Yinchuan, Ningxia, 750004, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

No. 451 Hospital

Xi'an, Shaanxi, 710054, China

Location

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Urumqi General Hospital of Lanzhou Military Region

Ürümqi, Xinjiang, 830002, China

Location

Related Publications (3)

  • 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.

    PMID: 23164513RESULT

  • 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.

    PMID: 22494121RESULT

  • 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.

    PMID: 27133971DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Hui Luo
Organization
Xijing hospital of digestive diseases
fmmulh@163.com
862984771536

Study Officials

  • Yanglin Pan, M.D.

    Xijing Hospital of Digestive Diseases.The Fourth Military Medical University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 6, 2013

Study Start

December 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

June 29, 2016

Results First Posted

May 27, 2016

Record last verified: 2016-05

Locations

CN(6)