Cholangiopancreatography, Endoscopic RetrogradeNCT04559867
Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
A study testing Needle knife fistulotomy and Sphincterotomy in people with Cholangiopancreatography, Endoscopic Retrograde and Biliary Tract Diseases, run by Lawrence Charles Hookey at 1 site in Canada.
Trial summary
Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Biliary Tract Diseases
- What is being tested?
- Needle knife fistulotomy and Sphincterotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 1 siteCanada
- Study dates
- 10 Sep 2020to 10 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients, greater than, or equal to 18 years of age, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications include: other benign biliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome requiring biliary decompression. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study.
- Ability to read and understand the English language,
- Ability to follow-up in a reliable manner.
Who cannot join
- Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5),
- Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC),
- P2Y12 inhibitors not held for 5 days prior to the procedure,
- Prior biliary sphincterotomy,
- Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),
- Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy),
Show all 14Show fewer
- Inability to achieve adequate sedation,
- Evidence of malignant infiltration of the ampulla or peri-ampullary area,
- Pregnancy,
- Operator inability to access and identify intra-duodenal portion of the bile duct,
- Presumptive diagnosis of sphincter of Oddi dysfunction,
- Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum),
- Requirement for pancreatogram or pancreatic intervention,
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts.
Patients will consent to allow the study physician to access these areas of the digestive system by either making a cut called a needle-knife fistulotomy or a sphincterotomy.
Read the detailed description
The ERCP procedure enables the study doctor to examine regions of the digestive system called the pancreas and bile ducts. After a patient is sedated, a bendable tube with a light (called an endoscope), is inserted through the mouth and into the digestive system. Within the digestive system, the doctor is able to identify the opening to where the gallbladder drains into the small bowel called the ampulla. Using the endoscope, a small plastic tube is then placed in the opening and dye (also called contrast material) is injected into the bile duct (area where bile leaves the liver). X-ray pictures can then be taken to provide further information to the doctor.
During the procedure, it is necessary to make a cut to enlarge the opening to allow easier removal of stones from the bile duct or to place plastic tubes (stents) in the bile duct. To make this cut, there are two different approaches that the doctor can take:
- The standard way of making the cut is referred to as a "sphincterotomy". Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.
- The second way of making the cut is referred to as a "pre-cut". There are various types of "pre-cut" techniques; the technique being evaluated in this study is called the "needle knife fistulotomy". When using this technique, the doctor makes a cut directly into the bile duct using a tiny knife called a "needle knife".
Currently, the doctor determines which cutting technique to use. The decision is entirely up to the individual doctor.
The purpose of this study, called a randomized, controlled trial, is to compare the safety and effectiveness of the two different approaches to the ERCP.
This type of study involves a large number of participants and the results may answer the question as to which approach should be used for patients having the ERCP procedure. The results may change the standard way that doctors conduct this procedure.
- Being tested
- Needle knife fistulotomy, Sphincterotomy
- Keywords
- Needle Knife Fistulotomy, Sphincterotomy, Post-ERCP pancreatitis
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle knife fistulotomyProcedure or surgery
A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP.
SphincterotomyProcedure or surgery
A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.
| Study group | Role | What they receive |
|---|---|---|
| Needle Knife Fistulotomy | Active comparator | The study doctor will gain access to the bile ducts using the cutting technique called a needle knife fistulotomy. When using this technique, the study doctor makes a cut directly into the bile duct. Receives: Procedure: Needle knife fistulotomy |
| Sphincterotomy | Active comparator | The study doctor will gain access to the bile ducts using the cutting technique called a sphincterotomy. Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it. Receives: Procedure: Sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis
The primary objective to be examined is the incidence of post-ERCP pancreatitis.
Measured: Up to 7 days
Secondary outcomes (7)
Cannulation Success Rate
Rate of successful cannulation of the common bile duct, with technical success determined by a cholangiogram.
Measured: Day 0
Inspection Time
Inspection time of the ampulla, defined as the visualization of the ampulla to the appearance of the needle knife or sphinctertome.
Measured: Day 0
Time to successful cannulation
For the sphincterotomy group, time to successful cannulation is defined as time of endoscopic visualization of the sphinctertome on the screen to contact with the papilla orifice. For the NKF group, this is defined as the time of endoscopic visualization of the metal point of the needle knife on the screen to successful cannulation of the common bile duct as evident by the cholangiogram or wire advancement into the common bile duct.
Measured: Day 0
Total procedure time
Total procedure time is measured for completed procedures from the time of esophageal intubation to the time of scope withdrawal from the patient mouth.
Measured: Day 0
Ampullary morphology
The type of ampulla, as determined by the study doctor.
Measured: Day 0
Difficulty of cannulation
Difficulty of cannulation, as graded on a 3-point scale, based on the study doctor's subjective opinion.
Measured: Day 0
Incidence of complications
Incidence of complications, notably intraprocedural bleeding that required intervention, delayed or sustained bleeding requiring transfusion or repeat endoscopy, and immediate or delayed perforation.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start10 Sep 2020
- Primary completion30 Mar 2024
- Study completion10 Dec 2024 (estimated)
Why it stopped: slower than expected recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- During the procedure, the study doctor will evaluate the participant's anatomy to determine if both approaches are possible to safely perform. If both approaches are assessed as safe to perform, then the participant will be randomly assigned (like the toss of a coin) to one approach. If the study doctor is unable to gain access using the approach the patient is initially assigned to, then they will switch approaches and use the other approach.
- Masking
- None (open label)
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lawrence Charles Hookey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lawrence Charles Hookey, Queen's University
- Investigators
- Robert Bechara, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559867
- Sponsor's protocol ID
- 6029074
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davee T, Garcia JA, Baron TH. Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol. 2012;25(4):291-302.
PubMed 24714256Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol. 2007 Apr 21;13(15):2183-6. doi: 10.3748/wjg.v13.i15.2183.
PubMed 17465498ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.
PubMed 27546389Andrade-Davila VF, Chavez-Tostado M, Davalos-Cobian C, Garcia-Correa J, Montano-Loza A, Fuentes-Orozco C, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Cortes-Lares JA, Ambriz-Gonzalez G, Cortes-Flores AO, Alvarez-Villasenor Adel S, Gonzalez-Ojeda A. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol. 2015 Jul 21;15:85. doi: 10.1186/s12876-015-0314-2.
PubMed 26195123Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.
PubMed 23920031Shaygan-Nejad A, Masjedizadeh AR, Ghavidel A, Ghojazadeh M, Khoshbaten M. Aggressive hydration with Lactated Ringer's solution as the prophylactic intervention for postendoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled double-blind clinical trial. J Res Med Sci. 2015 Sep;20(9):838-43. doi: 10.4103/1735-1995.170597.
PubMed 26759569Cavallini G, Tittobello A, Frulloni L, Masci E, Mariana A, Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography. Gabexate in digestive endoscopy--Italian Group. N Engl J Med. 1996 Sep 26;335(13):919-23. doi: 10.1056/NEJM199609263351302.
PubMed 8786777Manes G, Ardizzone S, Lombardi G, Uomo G, Pieramico O, Porro GB. Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study. Gastrointest Endosc. 2007 Jun;65(7):982-7. doi: 10.1016/j.gie.2007.02.055.
PubMed 17531632Andriulli A, Clemente R, Solmi L, Terruzzi V, Suriani R, Sigillito A, Leandro G, Leo P, De Maio G, Perri F. Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. Gastrointest Endosc. 2002 Oct;56(4):488-95. doi: 10.1067/mge.2002.128130.
PubMed 12297762Andriulli A, Solmi L, Loperfido S, Leo P, Festa V, Belmonte A, Spirito F, Silla M, Forte G, Terruzzi V, Marenco G, Ciliberto E, Sabatino A, Monica F, Magnolia MR, Perri F. Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate. Clin Gastroenterol Hepatol. 2004 Aug;2(8):713-8. doi: 10.1016/s1542-3565(04)00295-2.
PubMed 15290665Yuhara H, Ogawa M, Kawaguchi Y, Igarashi M, Shimosegawa T, Mine T. Pharmacologic prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: protease inhibitors and NSAIDs in a meta-analysis. J Gastroenterol. 2014 Mar;49(3):388-99. doi: 10.1007/s00535-013-0834-x. Epub 2013 May 30.
PubMed 23720090Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
PubMed 8782497Katsinelos P, Gkagkalis S, Chatzimavroudis G, Beltsis A, Terzoudis S, Zavos C, Gatopoulou A, Lazaraki G, Vasiliadis T, Kountouras J. Comparison of three types of precut technique to achieve common bile duct cannulation: a retrospective analysis of 274 cases. Dig Dis Sci. 2012 Dec;57(12):3286-92. doi: 10.1007/s10620-012-2271-8. Epub 2012 Jun 20.
PubMed 22714730Sundaralingam P, Masson P, Bourke MJ. Early Precut Sphincterotomy Does Not Increase Risk During Endoscopic Retrograde Cholangiopancreatography in Patients With Difficult Biliary Access: A Meta-analysis of Randomized Controlled Trials. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1722-1729.e2. doi: 10.1016/j.cgh.2015.06.035. Epub 2015 Jul 2.
PubMed 26144018Ayoubi M, Sansoe G, Leone N, Castellino F. Comparison between needle-knife fistulotomy and standard cannulation in ERCP. World J Gastrointest Endosc. 2012 Sep 16;4(9):398-404. doi: 10.4253/wjge.v4.i9.398.
PubMed 23125897
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04559867
- Acronym / sponsor ID
- 6029074
- Keywords
- Needle Knife Fistulotomy, Sphincterotomy, Post-ERCP pancreatitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: slower than expected recruitment
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Lawrence Charles HookeyUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 10 Dec 2024 (estimated)
- First posted
- 23 Sep 2020 (actual)
- 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.
Participants in this study will be undergoing a procedure called an endoscopic retrograde cholangiopancreatography (ERCP). This procedure is most commonly performed to help treat conditions affecting specific areas of the digestive system called the pancreas and bile ducts.
Patients will consent to allow the study physician to access these areas of the digestive system by either making a cut called a needle-knife fistulotomy or a sphincterotomy.
Detailed description
The ERCP procedure enables the study doctor to examine regions of the digestive system called the pancreas and bile ducts. After a patient is sedated, a bendable tube with a light (called an endoscope), is inserted through the mouth and into the digestive system. Within the digestive system, the doctor is able to identify the opening to where the gallbladder drains into the small bowel called the ampulla. Using the endoscope, a small plastic tube is then placed in the opening and dye (also called contrast material) is injected into the bile duct (area where bile leaves the liver). X-ray pictures can then be taken to provide further information to the doctor.
During the procedure, it is necessary to make a cut to enlarge the opening to allow easier removal of stones from the bile duct or to place plastic tubes (stents) in the bile duct. To make this cut, there are two different approaches that the doctor can take:
- The standard way of making the cut is referred to as a "sphincterotomy". Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it.
- The second way of making the cut is referred to as a "pre-cut". There are various types of "pre-cut" techniques; the technique being evaluated in this study is called the "needle knife fistulotomy". When using this technique, the doctor makes a cut directly into the bile duct using a tiny knife called a "needle knife".
Currently, the doctor determines which cutting technique to use. The decision is entirely up to the individual doctor.
The purpose of this study, called a randomized, controlled trial, is to compare the safety and effectiveness of the two different approaches to the ERCP.
This type of study involves a large number of participants and the results may answer the question as to which approach should be used for patients having the ERCP procedure. The results may change the standard way that doctors conduct this procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the procedure, the study doctor will evaluate the participant's anatomy to determine if both approaches are possible to safely perform. If both approaches are assessed as safe to perform, then the participant will be randomly assigned (like the toss of a coin) to one approach. If the study doctor is unable to gain access using the approach the patient is initially assigned to, then they will switch approaches and use the other approach.
| Arm | Type | Receives |
|---|---|---|
| Needle Knife Fistulotomy | Active comparator | Procedure: Needle knife fistulotomyThe study doctor will gain access to the bile ducts using the cutting technique called a needle knife fistulotomy. When using this technique, the study doctor makes a cut directly into the bile duct. |
| Sphincterotomy | Active comparator | Procedure: SphincterotomyThe study doctor will gain access to the bile ducts using the cutting technique called a sphincterotomy. Using this method, a heated metal wire cuts the opening to the bile duct after a wire has been passed into it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients, greater than, or equal to 18 years of age, with an intact sphincter undergoing ERCP by at Kingston Health Sciences Center for therapeutic purposes who can provide informed consent. This includes patients who have confirmed choledocholithiasis on imaging and those who have a high suspicion of it based on imaging and lab values. Patients with and without a high suspicion for cholangitis will be eligible for the study. Other indications include: other benign biliary duct diseases including strictures, primary sclerosing cholangitis and Mirizzi's syndrome requiring biliary decompression. Furthermore, patients with suspected diagnosis of biliary leak following cholecystectomy will also be considered for enrollment in this study.
- Ability to read and understand the English language,
- Ability to follow-up in a reliable manner.
Key exclusion criteria (14 listed)
- Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5),
- Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC),
- P2Y12 inhibitors not held for 5 days prior to the procedure,
- Prior biliary sphincterotomy,
- Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),
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 |
|---|---|---|
| Needle knife fistulotomyA needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP. | Procedure or surgery | Needle Knife Fistulotomy |
| SphincterotomyA sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it. | Procedure or surgery | Sphincterotomy |
Primary outcome
Post-ERCP pancreatitis
Time frame: Up to 7 days
The primary objective to be examined is the incidence of post-ERCP pancreatitis.
7 secondary outcomes
Cannulation Success Rate
Time frame: Day 0
Inspection Time
Time frame: Day 0
Time to successful cannulation
Time frame: Day 0
Total procedure time
Time frame: Day 0
Ampullary morphology
Time frame: Day 0
Difficulty of cannulation
Time frame: Day 0
Incidence of complications
Time frame: Up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 24714256Davee T, Garcia JA, Baron TH. Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol. 2012;25(4):291-302.
- Background: PubMed 17465498Robison LS, Varadarajulu S, Wilcox CM. Safety and success of precut biliary sphincterotomy: Is it linked to experience or expertise? World J Gastroenterol. 2007 Apr 21;13(15):2183-6. doi: 10.3748/wjg.v13.i15.2183.
- Background: PubMed 27546389ASGE Standards of Practice Committee; Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, Eloubeidi MA, Fanelli RD, Faulx AL, Gurudu SR, Kothari S, Lightdale JR, Qumseya BJ, Shaukat A, Wang A, Wani SB, Yang J, DeWitt JM. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32-47. doi: 10.1016/j.gie.2016.06.051. Epub 2016 Aug 18. No abstract available.
- Background: PubMed 26195123Andrade-Davila VF, Chavez-Tostado M, Davalos-Cobian C, Garcia-Correa J, Montano-Loza A, Fuentes-Orozco C, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Cortes-Lares JA, Ambriz-Gonzalez G, Cortes-Flores AO, Alvarez-Villasenor Adel S, Gonzalez-Ojeda A. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol. 2015 Jul 21;15:85. doi: 10.1186/s12876-015-0314-2.
- Background: PubMed 23920031Buxbaum J, Yan A, Yeh K, Lane C, Nguyen N, Laine L. Aggressive hydration with lactated Ringer's solution reduces pancreatitis after endoscopic retrograde cholangiopancreatography. Clin Gastroenterol Hepatol. 2014 Feb;12(2):303-7.e1. doi: 10.1016/j.cgh.2013.07.026. Epub 2013 Aug 3.
- Background: PubMed 26759569Shaygan-Nejad A, Masjedizadeh AR, Ghavidel A, Ghojazadeh M, Khoshbaten M. Aggressive hydration with Lactated Ringer's solution as the prophylactic intervention for postendoscopic retrograde cholangiopancreatography pancreatitis: A randomized controlled double-blind clinical trial. J Res Med Sci. 2015 Sep;20(9):838-43. doi: 10.4103/1735-1995.170597.
- Background: PubMed 8786777Cavallini G, Tittobello A, Frulloni L, Masci E, Mariana A, Di Francesco V. Gabexate for the prevention of pancreatic damage related to endoscopic retrograde cholangiopancreatography. Gabexate in digestive endoscopy--Italian Group. N Engl J Med. 1996 Sep 26;335(13):919-23. doi: 10.1056/NEJM199609263351302.
- Background: PubMed 17531632Manes G, Ardizzone S, Lombardi G, Uomo G, Pieramico O, Porro GB. Efficacy of postprocedure administration of gabexate mesylate in the prevention of post-ERCP pancreatitis: a randomized, controlled, multicenter study. Gastrointest Endosc. 2007 Jun;65(7):982-7. doi: 10.1016/j.gie.2007.02.055.
- Background: PubMed 12297762Andriulli A, Clemente R, Solmi L, Terruzzi V, Suriani R, Sigillito A, Leandro G, Leo P, De Maio G, Perri F. Gabexate or somatostatin administration before ERCP in patients at high risk for post-ERCP pancreatitis: a multicenter, placebo-controlled, randomized clinical trial. Gastrointest Endosc. 2002 Oct;56(4):488-95. doi: 10.1067/mge.2002.128130.
- Background: PubMed 15290665Andriulli A, Solmi L, Loperfido S, Leo P, Festa V, Belmonte A, Spirito F, Silla M, Forte G, Terruzzi V, Marenco G, Ciliberto E, Sabatino A, Monica F, Magnolia MR, Perri F. Prophylaxis of ERCP-related pancreatitis: a randomized, controlled trial of somatostatin and gabexate mesylate. Clin Gastroenterol Hepatol. 2004 Aug;2(8):713-8. doi: 10.1016/s1542-3565(04)00295-2.
- Background: PubMed 23720090Yuhara H, Ogawa M, Kawaguchi Y, Igarashi M, Shimosegawa T, Mine T. Pharmacologic prophylaxis of post-endoscopic retrograde cholangiopancreatography pancreatitis: protease inhibitors and NSAIDs in a meta-analysis. J Gastroenterol. 2014 Mar;49(3):388-99. doi: 10.1007/s00535-013-0834-x. Epub 2013 May 30.
- Background: PubMed 8782497Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
- 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.
Robert Bechara, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle knife fistulotomy and Sphincterotomy in people with Cholangiopancreatography, Endoscopic Retrograde and Biliary Tract Diseases, run by Lawrence Charles Hookey at 1 site in Canada.
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 3 inclusion and 14 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: paused, as of the sponsor's last update on 3 Apr 2024. 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 Canada. 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. 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?
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?
Post-ERCP pancreatitis (time frame: Up to 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 NCT04559867, which also lists 20 linked publications.
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 3 Apr 2024.