7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients

NCT04145336 | Unknown DMC

• 1 other identifier: KY20191010-2
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

ERCP; PEP; Post-ERCP pancreatitis; Pancreatic duct stent

Outcome Measures

Primary Outcomes (1)

• Post-ERCP Pancreatitis

  The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.

  14 days

Secondary Outcomes (2)

• Moderate to severe PEP

  14 days

• Other complications of ERCP

  14 days

Study Arms (2)

5cm PDS group

ACTIVE COMPARATOR

All patients in this group receive 5cm 5-Fr PDS.

Device: 5cm 5-Fr PDS; Drug: Indomethacin

7cm PDS group

EXPERIMENTAL

All patients in this group receive 7cm 5-Fr PDS.

Device: 7cm 5-Fr PDS; Drug: Indomethacin

Interventions

5cm 5-Fr PDS DEVICE

High-risk patients receive 5cm 5-Fr PDS

5cm PDS group

7cm 5-Fr PDS DEVICE

High-risk patients receive 7cm 5-Fr PDS

7cm PDS group

Indomethacin DRUG

All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.

5cm PDS group; 7cm PDS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Un-intentional pancreatic duct cannulation:
• or more times;
• time with more than 10 minutes cannulation.
• Double-wire technique;
• High-risk patients:
• met at least 1 of the major criteria
• Clinical suspicion of sphincter of Oddi dysfunction;
• Pancreatic sphincterotomy
• Delayed precut sphincterotomy
• ≥ 8 cannulation attempts
• Pneumatic dilatation of an intact biliary sphincter
• Ampullectomy
• or met at least 2 or more of the minor criteria
• Age \< 50;
• Female;

You may not qualify if:

• Therapeutic PDS;
• Acute pancreatitis within 3 days;
• With a history of pancreatic surgery or biliary-enteric anastomosis;
• Pregnant or breastfeeding women;
• unwilling or inability to provide consent.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

Related Publications (3)

• Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.

  PMID: 30340220 BACKGROUND

• Sugimoto M, Takagi T, Suzuki R, Konno N, Asama H, Sato Y, Irie H, Watanabe K, Nakamura J, Kikuchi H, Waragai Y, Takasumi M, Hikichi T, Ohira H. Pancreatic stents for the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis should be inserted up to the pancreatic body or tail. World J Gastroenterol. 2018 Jun 14;24(22):2392-2399. doi: 10.3748/wjg.v24.i22.2392.

  PMID: 29904246 BACKGROUND

• Olsson G, Lubbe J, Arnelo U, Jonas E, Tornqvist B, Lundell L, Enochsson L. The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study. United European Gastroenterol J. 2017 Feb;5(1):111-118. doi: 10.1177/2050640616645434. Epub 2016 Jul 8.

  PMID: 28405329 BACKGROUND

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 30, 2019
• Study Start: October 15, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

CN (1)