Clinical trial NCT04145336: 7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Keywords: ERCP
PEP
Post-ERCP pancreatitis
Pancreatic duct stent
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Post-ERCP Pancreatitis
timeFrame: 14 days
Secondary outcomes:
measure: Moderate to severe PEP
timeFrame: 14 days
measure: Other complications of ERCP
timeFrame: 14 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Diseases
state: Shanxi
Study officials:
References:
citation: 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.
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.
citation: 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.