Comparative Effectiveness Between Rectally Administered Indomethacin and Pancreatic Stenting in the Prevention of Post Endoscopic Retrograde Cholangio-panceaticography (ERCP) Pancreatitis: a Randomized Trial

Who is this study for? Patients at high risk for Post-ERCP Pancreatitis
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Post ERCP pancreatitis (PEP) occurs in 4 to 5% of patients and is associated with significant morbidities and occasional mortalities. The use of rectall administered indomethacin and pancreatic duct stent (PDS) placement have independently been proven to reduce PEP. The comparative effectiveness of the two methods has however not been studied. It is argued that in the context of indomethacin, the placement of a PDS is unnecessary. Advocates for PDS insertion however believe that mechanical decompression of the pancreatic duct is critical in the prevention of pancreatitis. The investigators propose a multi-centre randomised controlled trial to compare the use of rectal indomethacin to PDS insertion in high risk patients in the prevention of PEP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

⁃ presence of one of the following risk factors for Post ERCP Pancreatitis

• sphincter of Oddi dysfunction

• history of PEP, pancreatic instrumentation or sphincterotomy, precut sphincterotomy,

• difficult cannulation defined by \>5 cannulation attempts

• the use of double wire technique in bile duct access

• at least 2 of the followings including i) female age\<50 ii) 3 pancreatograms iii) acinarization (contrast injection to tail fo pancreas). iv) normal bilirubin; v)guidewire to the tail of pancreas or secondary branches.

Locations
Other Locations
China
Endoscopy centre
RECRUITING
Hangzhou
Eastern Hepatobiliary Surgery Hospital,Endoscopy centre
RECRUITING
Shanghai
Endoscopy centre
NOT_YET_RECRUITING
Shanghai
Endoscopy centre
RECRUITING
Tianjin
Endoscopy centre
RECRUITING
Xi'an
Hong Kong Special Administrative Region
Endoscopy Centre, Prince of Wales Hospital
RECRUITING
Hong Kong
Thailand
2. Chulalongkorn University and King Chulalongkorn Memorial Hospital
RECRUITING
Bangkok
Contact Information
Primary
James LAU, MD
laujyw@surgery.cuhk.edu.hk
35051411
Backup
RAYMOND TANG, MD
raymondtang@cuhk.edu.hk
35052640
Time Frame
Start Date: 2019-03-21
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 1734
Treatments
Experimental: indomethacin
rectal indomethacin 100 mg to be administered before or after ERCP
Experimental: pancreatic stenting
a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025 or .035 wire)
Experimental: indomethacin plus pancreatic stenting
\[rectal indomethacin 100 mg to be administered before or after ERCP\] plus \[a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025 or .035 wire\]
Sponsors
Collaborators: Zhejiang University, Xijing Hospital, Tianjin Union Medical Center, Eastern Hepatobiliary Surgery Hospital, Changhai Hospital
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov