A COMBINATION OF RECTAL INDOMETHACIN AND COLD WATER EXPOSURE OF THE AMPULLA AFTER ERCP IS SUPERIOR TO RECTAL INDOMETHACIN ALONE IN REDUCING THE INCIDENCE OF POST-ERCP PANCREATITIS -RCT

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorAsian Institute of Gastroenterology, India

About this trial

Endoscopic retrograde cholangiopancreatography (ERCP) has emerged as the primary modality in the management of biliary and pancreatic disease. The complications occurring from ERCP can range from mild to fatal. Procedure related complications are Pancreatitis , Bleeding , Infections- Cholangitis, Cholecystitis , Perforations of which Post-ERCP pancreatitis (PEP) is the most common serious adverse event. Reported incidence of PEP is 8.6-10.7% according to studies(overall RCTs).In India it is 6.6% (2020 study). Prevention as well as early detection and management of PEP results in a satisfactory outcome. Multiple RCTs and meta-analyses show rectal indomethacin/diclofenac significantly reduce PEP in average- and high-risk patients; now recommended by ASGE/ESGE for nearly all ERCPs. Other measures for prevention of PEP are prophylactic pancreatic duct stents in high-risk anatomy/instrumentation; wire-guided cannulation; minimizing PD contrast; periprocedural aggressive lactated Ringer's hydration. Cryoprevention effect was shown to reduce postprocedure papillary edema and thus lower the risk of PEP

1. Rectal NSAIDs reduce but do not eliminate PEP. 2. Cold-water ampullary cooling is biologically plausible but under-studied. 3. First study to demonstrate if combination of rectal indomethacin and cold-water irrigation may have a synergistic effect. 4. First study in Indian population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Standard ERCP indication

Consent given

Disqualifiers

Pregnancy and lactation

Chronic calcific pancreatitis / pancreatic divisum / pancreatic head

malignancy / acute pancreatitis within 14 days of ERCP

ERCP for biliary/pancreatic stent exchange or removal or prior biliary sphincterotomy

Trial population

150

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Rectal Indomethacin plus Papilary spay of Cold saline
Group B: Rectal Indomethacin alone

Trial outcomes

Primary outcomes

1

Categorisation of Post ERCP Pancreatitis

Incidence of Post ERCP Pancreatitis by Cotton criteria: severity graded as mild/ moderate/ severe per consensus

Time frame
10 Days

Secondary outcomes

1

Serum amylase and lipase 24 hours post ERCP.

To evaluate the serum amylase and lipase levels 24 hours after ERCP procedure

Time frame
24 hours
2

Abdomen pain score assessment

To check pain levels every 4 hours up to 24 hours post ERCP procedure

Time frame
24 hours
3

Adverse events detection : GI bleeding, perforation, cholangitis, aspiration, hypoxemia

To detect adverse events post procedure

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.