Pancreatitis, AcuteNCT02959112
Epinephrine Sprayed on the Papilla Versus Sterile Water Sprayed on the Papilla for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography
A study testing Epinephrine, Sterile water and Indomethacin Rectal Suppository in people with Pancreatitis, Acute, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatitis, Acute
- What is being tested?
- Epinephrine, Sterile water and Indomethacin Rectal Suppository
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 548 participants
- Where
- 1 siteMexico
- Study dates
- May 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patient with an indication for endoscopic retrograde cholangiopancreatography
- Patient without prior endoscopic retrograde cholangiopancreatography
- Patient who accept contact by telephone
Who cannot join
- Previous sphincterotomy
- Allergy to epinephrine or indomethacin
- NSAIDs use in the prior week
- Pancreatic cancer located in the head
- Chronic pancreatitis
- Renal failure (Cr >1.4 mg / dl)
Show all 9Show fewer
- Indication for endotracheal intubation independent of endoscopic retrograde cholangiopancreatography
- Biliodigestive derivation
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14000
About this study
Official title: Epinephrine Sprayed on the Papilla and Rectal Indomethacin Versus Sterile Water Sprayed on the Papilla and Rectal Indomethacin for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Controlled Trial
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure.
Read the detailed description
This multicentre randomised placebo-controlled trial was conducted in two hospitals in Mexico: the National Institute of Medical Sciences and Nutrition "Salvador Zubirán" (INCMNSZ) in Mexico City, and Bernardette Hospital in Jalisco. The study was approved by both institutional review boards. All patients provided written informed consent.
All patients were given a dose of rectal indomethacin (100 mg) at the beginning of the ERCP. Depending on the experimental group, either 10 ml of sterile water or 10 ml of a 1:10,000 epinephrine dilution (0.1 mg/ml) was sprayed on the ampulla through a biliary balloon or a sphincterotome, avoiding any direct contact with the papilla during irrigation at the end of the procedure.
After the procedure, patients were monitored in the recovery room for 2 hours and then discharged. Symptoms of acute pancreatitis or any other complication were interrogated at baseline while in the recovery room, and then by telephone 24 hours and 7 days after the procedure. Serum levels of pancreatic enzymes were determined only if the patient developed abdominal pain after ERCP.
- Conditions
- Pancreatitis, Acute
- Being tested
- Epinephrine, Sterile water, Indomethacin Rectal Suppository
- Keywords
- pancreatitis after ERCP, epinephrine, papilla, rectal indomethacin
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Sterile waterOther
Indomethacin Rectal SuppositoryDrug
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine sprayed on the papilla and rectal indomethacin | Active comparator | Epinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Receives: Drug: Epinephrine; Other: Sterile water; Drug: Indomethacin Rectal Suppository |
| Sterile water sprayed on the papilla and rectal indomethacin | Placebo comparator | 10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure Receives: Other: Sterile water; Drug: Indomethacin Rectal Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition
Consensus definition for post endoscopic retrograde cholangiopancreatography pancreatitis is: (1) new or worsened abdominal pain, (2) new or prolongation of hospitalization for at least 2 days, and (3) serum amylase or lipase 3 times or more the upper limit of normal, measured more than 24 hours after the procedure
Measured: 7 days
Secondary outcomes (1)
Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Because previous studies had found no difference, and one recent study even reported a higher incidence of PEP in treatment arm
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated into groups by block randomisation using computed-generated numbers. The two groups were rectal indomethacin and epinephrine sprayed on the ampulla versus rectal indomethacin and sham water spray.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FELIX IGNACIO TELLEZ AVILA, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959112
- Sponsor's protocol ID
- 2008
- Status last verified
- Feb 2020
- First submitted
- 31 Oct 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Romano-Munive AF, Garcia-Correa JJ, Garcia-Contreras LF, Ramirez-Garcia J, Uscanga L, Barbero-Becerra VJ, Moctezuma-Velazquez C, Ochoa-Rubi JA, Toledo-Cuque J, Vazquez-Anaya G, Keil-Rios D, Grajales-Figueroa G, Ramirez-Luna MA, Valdovinos-Andraca F, Zamora-Nava LE, Tellez-Avila F. Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial. BMJ Open Gastroenterol. 2021 Feb;8(1):e000562. doi: 10.1136/bmjgast-2020-000562.
PubMed 33558263
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine Sprayed on the Papilla and Rectal Indomethacin Versus Sterile Water Sprayed on the Papilla and Rectal Indomethacin for Preventing Pancreatitis After Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02959112
- Acronym / sponsor ID
- 2008
- Conditions
- Pancreatitis, Acute
- Keywords
- pancreatitis after ERCP, epinephrine, papilla, rectal indomethacin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because previous studies had found no difference, and one recent study even reported a higher incidence of PEP in treatment arm
- Enrolment
- 548 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicentre randomised controlled trial included patients aged >18 years with an indication for ERCP and naive major papilla. All patients received 100 mg of rectal indomethacin and 10 ml of either sterile water or a 1:10,000 epinephrine dilution. Patients were asked about PEP symptoms via telephone 24 hours and 7 days after the procedure.
Detailed description
This multicentre randomised placebo-controlled trial was conducted in two hospitals in Mexico: the National Institute of Medical Sciences and Nutrition "Salvador Zubirán" (INCMNSZ) in Mexico City, and Bernardette Hospital in Jalisco. The study was approved by both institutional review boards. All patients provided written informed consent.
All patients were given a dose of rectal indomethacin (100 mg) at the beginning of the ERCP. Depending on the experimental group, either 10 ml of sterile water or 10 ml of a 1:10,000 epinephrine dilution (0.1 mg/ml) was sprayed on the ampulla through a biliary balloon or a sphincterotome, avoiding any direct contact with the papilla during irrigation at the end of the procedure.
After the procedure, patients were monitored in the recovery room for 2 hours and then discharged. Symptoms of acute pancreatitis or any other complication were interrogated at baseline while in the recovery room, and then by telephone 24 hours and 7 days after the procedure. Serum levels of pancreatic enzymes were determined only if the patient developed abdominal pain after ERCP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were allocated into groups by block randomisation using computed-generated numbers. The two groups were rectal indomethacin and epinephrine sprayed on the ampulla versus rectal indomethacin and sham water spray.
| Arm | Type | Receives |
|---|---|---|
| Epinephrine sprayed on the papilla and rectal indomethacin | Active comparator | Drug: Epinephrine, Other: Sterile water, Drug: Indomethacin Rectal SuppositoryEpinephrine 1 mg/1 mL + 9 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure |
| Sterile water sprayed on the papilla and rectal indomethacin | Placebo comparator | Other: Sterile water, Drug: Indomethacin Rectal Suppository10 mL of sterile water are sprayed on the papilla at the end of the endoscopic retrograde cholangiopancreatography and 100 mg of indomethacin rectal suppository is administered at the beginning of the procedure |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Patient with an indication for endoscopic retrograde cholangiopancreatography
- Patient without prior endoscopic retrograde cholangiopancreatography
- Patient who accept contact by telephone
Key exclusion criteria (9 listed)
- Previous sphincterotomy
- Allergy to epinephrine or indomethacin
- NSAIDs use in the prior week
- Pancreatic cancer located in the head
- Chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epinephrine | Drug | Epinephrine sprayed on the papilla and rectal indomethacin |
| Sterile water | Other | Epinephrine sprayed on the papilla and rectal indomethacin, Sterile water sprayed on the papilla and rectal indomethacin |
| Indomethacin Rectal Suppository | Drug | Epinephrine sprayed on the papilla and rectal indomethacin, Sterile water sprayed on the papilla and rectal indomethacin |
Primary outcome
Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition
Time frame: 7 days
Consensus definition for post endoscopic retrograde cholangiopancreatography pancreatitis is: (1) new or worsened abdominal pain, (2) new or prolongation of hospitalization for at least 2 days, and (3) serum amylase or lipase 3 times or more the upper limit of normal, measured more than 24 hours after the procedure
1 secondary outcome
Risk factors associated with the development of pancreatitis after endoscopic retrograde cholangiopancreatography assessed by relative risk
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Because previous studies had found no difference, and one recent study even reported a higher incidence of PEP in treatment arm). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 33558263Romano-Munive AF, Garcia-Correa JJ, Garcia-Contreras LF, Ramirez-Garcia J, Uscanga L, Barbero-Becerra VJ, Moctezuma-Velazquez C, Ochoa-Rubi JA, Toledo-Cuque J, Vazquez-Anaya G, Keil-Rios D, Grajales-Figueroa G, Ramirez-Luna MA, Valdovinos-Andraca F, Zamora-Nava LE, Tellez-Avila F. Can topical epinephrine application to the papilla prevent pancreatitis after endoscopic retrograde cholangiopancreatography? Results from a double blind, multicentre, placebo controlled, randomised clinical trial. BMJ Open Gastroenterol. 2021 Feb;8(1):e000562. doi: 10.1136/bmjgast-2020-000562.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine, Sterile water and Indomethacin Rectal Suppository in people with Pancreatitis, Acute, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because previous studies had found no difference, and one recent study even reported a higher incidence of PEP in treatment arm). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with pancreatitis after endoscopic retrograde cholangiopancreatography, used consensus definition (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02959112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.