Combination of Rectal Indomethacin and Pancreatic Duct Stenting Versus Indomethacin Alone in Preventing PEP

NCT04340687 | Completed DMC

• 1 other identifier: 20191115-2
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

Brief Summary

Rectal indomethacin and pancreatic duct (PD) stenting (PDS) are recommended for the prevention of post-ERCP pancreatitis (PEP). However, the effects of the combination of the two methods on preventing PEP are controversial. We hypothesized that some group of patients with difficult cannulation might benefit from the combination of indomethacin plus PDS (IP) compared with indomethacin alone (IN).

Conditions

Healthy

Keywords

Indomethacin; Double-guidewire technique; Adverse events; PEP; PD stenting

Outcome Measures

Primary Outcomes (1)

• Overall PEP

  PEP was diagnosed if there was a worsening or new onset of pain in the upper abdomen, an elevation in serum amylase of at least three times of the upper limit of the normal range 24h after the procedure and requiring at least two nights of hospitalization.

  30 days

Secondary Outcomes (1)

• Overall ERCP related complication

  30 days

Study Arms (2)

IP group

All patients recevied pancreatic duct stent during ERCP and one single dose of 100mg rectal indomethacin after ERCP.

Device: Pancreatic duct stenting

IN group

All patients received one single dose of 100mg rectal indomethacin after ERCP.

Interventions

Pancreatic duct stenting DEVICE

A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice

IP group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent ERCP and received administration of rectal indomethacin.

You may qualify if:

• Patients underwent diagnostic or therapeutic ERCP
• With native papilla
• With difficult cannulation (cannulation time \>10min or cannulation attempts \>5 times or inadvertently PD cannulation ≥1)
• Receiving post-ERCP rectal indomethacin

You may not qualify if:

• Patients with indications of PD cannulation
• No attempt of cannulation due to inaccessible papilla
• Non-difficult cannulation

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

Location

Related Publications (2)

• 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.

  PMID: 25148137 BACKGROUND

• Akbar A, Abu Dayyeh BK, Baron TH, Wang Z, Altayar O, Murad MH. Rectal nonsteroidal anti-inflammatory drugs are superior to pancreatic duct stents in preventing pancreatitis after endoscopic retrograde cholangiopancreatography: a network meta-analysis. Clin Gastroenterol Hepatol. 2013 Jul;11(7):778-83. doi: 10.1016/j.cgh.2012.12.043. Epub 2013 Jan 30.

  PMID: 23376320 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

CN (1)