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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04145336
• Other study ID #: KY20191010-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Un-intentional pancreatic duct cannulation:

• 2 or more times;

• 1 time with more than 10 minutes cannulation.

2. Double-wire technique;

3. 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;

• Normal TBIL;

• = 3 injections of contrast into the pancreatic duct with = 1 injection to the tail of the pancreas;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Device:
• 5cm 5-Fr PDS
High-risk patients receive 5cm 5-Fr PDS
• 7cm 5-Fr PDS
High-risk patients receive 7cm 5-Fr PDS

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

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Diseases	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Domagk D, Oppong KW, Aabakken L, Czakó L, Gyökeres 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. — View Citation

Olsson G, Lübbe J, Arnelo U, Jonas E, Törnqvist 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Moderate to severe PEP	The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.	14 days
Secondary	Other complications of ERCP	Other complications include post sphincterotomy bleeding, biliary infection, perforation, and any adverse outcomes possibly related to ERCP that required hospital admission or a prolonged hospital stay for further management.	14 days