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

Primary Purpose

Post-ERCP Acute Pancreatitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
5cm 5-Fr PDS
7cm 5-Fr PDS
Indomethacin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring ERCP, PEP, Post-ERCP pancreatitis, Pancreatic duct stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing Hospital of Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

5cm PDS group

7cm PDS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Moderate to severe PEP
The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.
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.

Full Information

First Posted
October 18, 2019
Last Updated
October 28, 2019
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04145336
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-ERCP Acute Pancreatitis
Keywords
ERCP, PEP, Post-ERCP pancreatitis, Pancreatic duct stent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5cm PDS group
Arm Type
Active Comparator
Arm Description
All patients in this group receive 5cm 5-Fr PDS.
Arm Title
7cm PDS group
Arm Type
Experimental
Arm Description
All patients in this group receive 7cm 5-Fr PDS.
Intervention Type
Device
Intervention Name(s)
5cm 5-Fr PDS
Intervention Description
High-risk patients receive 5cm 5-Fr PDS
Intervention Type
Device
Intervention Name(s)
7cm 5-Fr PDS
Intervention Description
High-risk patients receive 7cm 5-Fr PDS
Intervention Type
Drug
Intervention Name(s)
Indomethacin
Intervention Description
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
Primary Outcome Measure Information:
Title
Post-ERCP Pancreatitis
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Moderate to severe PEP
Description
The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.
Time Frame
14 days
Title
Other complications of ERCP
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Un-intentional pancreatic duct cannulation: 2 or more times; 1 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; 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.
Facility Information:
Facility Name
Xijing Hospital of Digestive Diseases
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
30340220
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.
Results Reference
background
PubMed Identifier
29904246
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.
Results Reference
background
PubMed Identifier
28405329
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.
Results Reference
background

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

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