Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

Biliary Tract Diseases Clinical Trial

Official title:

Fistulotomy as the Primary Cannulation Technique for All Patients Undergoing ERCP: A Randomized, Controlled Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04559867
• Other study ID #: 6029074
• Status: Suspended
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: December 10, 2024

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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:

1. 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.

2. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 538
• Est. completion date: December 10, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Ability to read and understand the English language,

3. Ability to follow-up in a reliable manner.

Exclusion Criteria:

1. Bleeding disorder (Von Willebrand disorder, platelet count <100 000, or INR >1.5),

2. Therapeutic level anticoagulation with low molecular weight heparin (LMWH), warfarin, or a direct-acting oral anticoagulant (DOAC),

3. P2Y12 inhibitors not held for 5 days prior to the procedure,

4. Prior biliary sphincterotomy,

5. Concurrent pancreatitis (with inability to tolerate oral intake and requiring pain management),

6. Altered upper GI tract anatomy (e.g. prior gastric bypass surgery such as Roux-en-Y or Billroth 2 gastrojejunostomy),

7. Inability to achieve adequate sedation,

8. Evidence of malignant infiltration of the ampulla or peri-ampullary area,

9. Pregnancy,

10. Operator inability to access and identify intra-duodenal portion of the bile duct,

11. Presumptive diagnosis of sphincter of Oddi dysfunction,

12. Inability to access intraduodenal segment due to altered anatomy (eg. ampulla within deep diverticulum),

13. Requirement for pancreatogram or pancreatic intervention,

14. Inability to provide informed consent.

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Cholangiopancreatography, Endoscopic Retrograde

Intervention

Procedure:
• Needle knife fistulotomy
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.
• Sphincterotomy
A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawrence Charles Hookey

Country where clinical trial is conducted

Canada, 

References & Publications (19)

Andrade-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. — View Citation

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Andriulli 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. — View Citation

ASGE 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. — View Citation

Ayoubi 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. — View Citation

Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25. — View Citation

Buxbaum 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. — View Citation

Cavallini 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. — View Citation

Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2. — View Citation

Davee T, Garcia JA, Baron TH. Precut sphincterotomy for selective biliary duct cannulation during endoscopic retrograde cholangiopancreatography. Ann Gastroenterol. 2012;25(4):291-302. — View Citation

Freeman 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. — View Citation

Jin YJ, Jeong S, Lee DH. Utility of needle-knife fistulotomy as an initial method of biliary cannulation to prevent post-ERCP pancreatitis in a highly selected at-risk group: a single-arm prospective feasibility study. Gastrointest Endosc. 2016 Nov;84(5):808-813. doi: 10.1016/j.gie.2016.04.011. Epub 2016 Apr 19. — View Citation

Katsinelos 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. — View Citation

Lopes L, Dinis-Ribeiro M, Rolanda C. Early precut fistulotomy for biliary access: time to change the paradigm of "the later, the better"? Gastrointest Endosc. 2014 Oct;80(4):634-641. doi: 10.1016/j.gie.2014.03.014. Epub 2014 May 6. — View Citation

Manes 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. — View Citation

Robison 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. — View Citation

Shaygan-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. — View Citation

Sundaralingam 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. — View Citation

Yuhara 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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-ERCP pancreatitis	The primary objective to be examined is the incidence of post-ERCP pancreatitis.	Up to 7 days
Secondary	Cannulation Success Rate	Rate of successful cannulation of the common bile duct, with technical success determined by a cholangiogram.	Day 0
Secondary	Inspection Time	Inspection time of the ampulla, defined as the visualization of the ampulla to the appearance of the needle knife or sphinctertome.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	Ampullary morphology	The type of ampulla, as determined by the study doctor.	Day 0
Secondary	Difficulty of cannulation	Difficulty of cannulation, as graded on a 3-point scale, based on the study doctor's subjective opinion.	Day 0
Secondary	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.	Up to 7 days