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

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

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.

Study Overview

• Status: Unknown
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Device: 5cm 5-Fr PDS; Drug: Indomethacin; Device: 7cm 5-Fr PDS

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5cm PDS group; All patients in this group receive 5cm 5-Fr PDS.	Device: 5cm 5-Fr PDS; High-risk patients receive 5cm 5-Fr PDS; Drug: Indomethacin; All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
Experimental: 7cm PDS group; All patients in this group receive 7cm 5-Fr PDS.	Drug: Indomethacin; All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.; Device: 7cm 5-Fr PDS; High-risk patients receive 7cm 5-Fr PDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Anticipated): October 31, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: ERCP; PEP; Pancreatic duct stent; Post-ERCP pancreatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Indomethacin
• Other Study ID Numbers: KY20191010-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No