Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
152 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-12
Study Completion Date
2024-10-21
Brief Summary
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A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.
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Detailed Description
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Endoscopic retrograde cholangiopancreatography (ERCP), an invasive procedure that combines endoscopy and x-ray to treat issues with the bile and pancreatic ducts, carries a two to ten percent risk of causing post-ERCP pancreatitis (PEP) \[1\]. Because acute pancreatitis is a devastating inflammatory condition that leads to extensive morbidity and mortality, efforts to reduce the risk of PEP in patients undergoing ERCP would enhance patient outcomes and would decrease the economic burden in treating PEP nationwide \[2-4\].
A difficult cannulation has been identified as one of the high risk factors for developing PEP \[5\]. A study performed by Scandinavian Association for Digestive Endoscopy (SADE) determined that cannulations with five or more attempts, a duration of five minutes or longer, or two or more unintended pancreatic duct (PD) wire passages significantly increased one's risk for PEP \[6\]. Thus, SADE defined a difficult cannulation as any cannulation with at least one of the following conditions: five or more attempts, five or more minutes, or two or more unintended PD wire passages \[6\]. This classification of a difficult cannulation has been adopted and standardized by the European Society of Gastrointestinal Endoscopy \[7\]. Because no current guidelines defining a difficult cannulation exist from the American College of Gastroenterology or American Gastroenterological Association, the European Society of Gastrointestinal Endoscopy (ESGE) guidelines as gathered from the SADE study are the worldwide standardized definition of difficult cannulation.
Difficult cannulations have been reported to occur at a frequency of 42 percent for all ERCP exams \[8\]. The morphology and accessibility of the papilla influence the level of difficulty. Some studies have indicated that different macroscopic appearances of the papilla result in varying cannulation difficulty levels. Based on a study gauging intraobserver and interobserver agreement to the macroscopic appearance of different papillae, papillae are categorized as: Type 1, normal appearing; Type 2, small; Type 3, protruding or pendulous; and Type 4, ridged or creased \[9\]. Haraldsson et al. found that Type 2 and Type 3 papillae were more difficult to cannulate \[8\]. Regardless of papilla type, the involvement of a trainee (a GI fellow) resulted in more difficult cannulations \[8\]. In addition, the presence of redundant tissue, such as periampullary diverticula-which occurs in up to 20 percent of patients undergoing ERCP-results in more challenging cannulations \[10\]. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access \[10-12\]. The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation \[10\]. Currently, no randomized controlled trials that detail to what extent a forceps facilitates cannulation exist. Thus, our study aims to determine whether a forceps assisted cannulation reduces the incidence of difficult cannulations and consequently PEP.
The primary outcome is difficult cannulation after randomization. A difficult cannulation will be defined as any cannulation that results in any of the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or more unintentional pancreatic wire passages.
The secondary outcome is PEP. Acute pancreatitis according to the Atlanta guidelines, is at least two of the following: abdominal pain consistent with pancreatitis, lipase or amylase greater than 3 times the upper limit of normal, radiographic evidence of pancreatitis on cross sectional imaging \[13\].
The study intervention is the use of a forceps during the cannulation. Eligible patients who have consented will either be randomized to forceps assisted cannulation or no forceps used during cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event.
SOCCER plans to enroll 152 patients. All patients undergoing ERCP at Dartmouth-Hitchcock endoscopy will be approached and consented for this study. Medical records will be reviewed to see if they meet inclusion/exclusion criteria. Patients will be consented day of the procedure. We received an approved HIPAA Authorization Waiver because access to a patient's chart will be required to determine inclusion/exclusion criteria.
Consent will be performed in the endoscopy pre-op area. During the standard of care ERCP, the patients will be randomized intraoperatively to either cannulation with forceps and cannulation with no forceps. Written informed consent will be reviewed and signed before any study related procedures are performed.
Please note that the primary outcome refers to a difficult cannulation AFTER randomization when the secondary inclusion criteria has been met. For example, if the secondary inclusion criteria met is difficult cannulation, then the primary outcome would be if from that point forward there were a difficult cannulation. As such, a total cannulation time of 10 minutes would enable the patient to be eligible (the first 5 minutes means the cannulation is difficult) and would mean the subject met the primary outcome (the second 5 minutes means cannulation after randomization is difficult). However, a total cannulation time of 8 minutes means the patient is eligible for the study (first 5 minutes means the cannulation is difficult) but did not meet the primary outcome (after randomization, the cannulation was not difficult because it was only 3 minutes). In a sense, the "difficult cannulation clock" is reset after randomization. If the secondary inclusion criteria met instead is papilla location or type, then the patient is randomized immediately before the cannulation and the difficult cannulation clock starts then. Measurement of difficult cannulation starts immediately after randomization upon the doctor's first cannulation attempt following randomization.
Randomization will occur in block format. Randomization assignments will be placed in sealed manila envelopes that will be opened at the time of randomization. Manila envelopes will be kept with the study coordinator.
After consent, data will be collected before, during, and after the procedure. The primary outcome will be measured during the procedure, whereas the secondary outcome will be determined during the 5 day follow up call. The study coordinator, GI fellow, or attending physician will call the patient 5 days (+/- 2 days) post-procedure to determine whether the patient developed PEP. Though it is preferred to contact the patient, other methods (chart review, emergency contact, outside records) are acceptable for determining the secondary outcome.
A difficult cannulation has been identified as one of the high risk factors for developing PEP \[5\]. A study performed by Scandinavian Association for Digestive Endoscopy (SADE) determined that cannulations with five or more attempts, a duration of five minutes or longer, or two or more unintended pancreatic duct (PD) wire passages significantly increased one's risk for PEP \[6\]. Thus, SADE defined a difficult cannulation as any cannulation with at least one of the following conditions: five or more attempts, five or more minutes, or two or more unintended PD wire passages \[6\]. This classification of a difficult cannulation has been adopted and standardized by the European Society of Gastrointestinal Endoscopy \[7\]. Because no current guidelines defining a difficult cannulation exist from the American College of Gastroenterology or American Gastroenterological Association, the European Society of Gastrointestinal Endoscopy (ESGE) guidelines as gathered from the SADE study are the worldwide standardized definition of difficult cannulation.
Difficult cannulations have been reported to occur at a frequency of 42 percent for all ERCP exams \[8\]. The morphology and accessibility of the papilla influence the level of difficulty. Some studies have indicated that different macroscopic appearances of the papilla result in varying cannulation difficulty levels. Based on a study gauging intraobserver and interobserver agreement to the macroscopic appearance of different papillae, papillae are categorized as: Type 1, normal appearing; Type 2, small; Type 3, protruding or pendulous; and Type 4, ridged or creased \[9\]. Haraldsson et al. found that Type 2 and Type 3 papillae were more difficult to cannulate \[8\]. Regardless of papilla type, the involvement of a trainee (a GI fellow) resulted in more difficult cannulations \[8\]. In addition, the presence of redundant tissue, such as periampullary diverticula-which occurs in up to 20 percent of patients undergoing ERCP-results in more challenging cannulations \[10\]. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access \[10-12\]. The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation \[10\]. Currently, no randomized controlled trials that detail to what extent a forceps facilitates cannulation exist. Thus, our study aims to determine whether a forceps assisted cannulation reduces the incidence of difficult cannulations and consequently PEP.
The primary outcome is difficult cannulation after randomization. A difficult cannulation will be defined as any cannulation that results in any of the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or more unintentional pancreatic wire passages.
The secondary outcome is PEP. Acute pancreatitis according to the Atlanta guidelines, is at least two of the following: abdominal pain consistent with pancreatitis, lipase or amylase greater than 3 times the upper limit of normal, radiographic evidence of pancreatitis on cross sectional imaging \[13\].
The study intervention is the use of a forceps during the cannulation. Eligible patients who have consented will either be randomized to forceps assisted cannulation or no forceps used during cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event.
SOCCER plans to enroll 152 patients. All patients undergoing ERCP at Dartmouth-Hitchcock endoscopy will be approached and consented for this study. Medical records will be reviewed to see if they meet inclusion/exclusion criteria. Patients will be consented day of the procedure. We received an approved HIPAA Authorization Waiver because access to a patient's chart will be required to determine inclusion/exclusion criteria.
Consent will be performed in the endoscopy pre-op area. During the standard of care ERCP, the patients will be randomized intraoperatively to either cannulation with forceps and cannulation with no forceps. Written informed consent will be reviewed and signed before any study related procedures are performed.
Please note that the primary outcome refers to a difficult cannulation AFTER randomization when the secondary inclusion criteria has been met. For example, if the secondary inclusion criteria met is difficult cannulation, then the primary outcome would be if from that point forward there were a difficult cannulation. As such, a total cannulation time of 10 minutes would enable the patient to be eligible (the first 5 minutes means the cannulation is difficult) and would mean the subject met the primary outcome (the second 5 minutes means cannulation after randomization is difficult). However, a total cannulation time of 8 minutes means the patient is eligible for the study (first 5 minutes means the cannulation is difficult) but did not meet the primary outcome (after randomization, the cannulation was not difficult because it was only 3 minutes). In a sense, the "difficult cannulation clock" is reset after randomization. If the secondary inclusion criteria met instead is papilla location or type, then the patient is randomized immediately before the cannulation and the difficult cannulation clock starts then. Measurement of difficult cannulation starts immediately after randomization upon the doctor's first cannulation attempt following randomization.
Randomization will occur in block format. Randomization assignments will be placed in sealed manila envelopes that will be opened at the time of randomization. Manila envelopes will be kept with the study coordinator.
After consent, data will be collected before, during, and after the procedure. The primary outcome will be measured during the procedure, whereas the secondary outcome will be determined during the 5 day follow up call. The study coordinator, GI fellow, or attending physician will call the patient 5 days (+/- 2 days) post-procedure to determine whether the patient developed PEP. Though it is preferred to contact the patient, other methods (chart review, emergency contact, outside records) are acceptable for determining the secondary outcome.
Conditions
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Post-ERCP Acute Pancreatitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Patients will be randomized to either ERCP with forceps assisted cannulation or ERCP with no forceps.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Patients will be unblinded to their treatment on the 5 (+/- 2) day follow-up call.
Study Groups
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Forceps Assisted Cannulation
Patients will have a forceps assisted cannulation during their ERCPs.
Group Type
EXPERIMENTAL
Forceps
Intervention Type
DEVICE
The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event. Please note that for the explicit purpose of the study the forceps will be used to grab tissue and not take biopsies. The forceps may still be used to take biopsies if the physician believes it is indicated.
No Forceps Assisted Cannulation
Patients will not have a forceps assisted cannulation during their ERCPs.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Forceps
The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the ampullary position to permit an easier cannulation. The forceps is an FDA approved instrument and does not put the patient at any higher risk for any adverse event. Please note that for the explicit purpose of the study the forceps will be used to grab tissue and not take biopsies. The forceps may still be used to take biopsies if the physician believes it is indicated.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Patient consent
* ERCP done on native papilla
* Papilla in a diverticulum
* Papilla on rim of a diverticulum
* Difficult cannulation (5 attempts, 5 minutes, or 2 unintended PD wire passages)
* Redundant tissue overlying papilla
* Type 2, 3, or 4 papilla
* ERCP done on native papilla
* Papilla in a diverticulum
* Papilla on rim of a diverticulum
* Difficult cannulation (5 attempts, 5 minutes, or 2 unintended PD wire passages)
* Redundant tissue overlying papilla
* Type 2, 3, or 4 papilla
Exclusion Criteria
* Prior ampullectomy
* Known pregnancy, positive test, breastfeeding
* Clinical contraindication to ERCP
* Metal allergy
* Prior sphincterotomy
* Inability to follow protocol
* \<18 years old
* Enrolled in another ERCP study
* Biliary/PD stent in place
* Known pregnancy, positive test, breastfeeding
* Clinical contraindication to ERCP
* Metal allergy
* Prior sphincterotomy
* Inability to follow protocol
* \<18 years old
* Enrolled in another ERCP study
* Biliary/PD stent in place
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Timothy Gardner
Principal Investigator, Staff Physician, Gastroenterology & Hepatology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Timothy B Gardner, MD MS
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Dartmouth Health
Lebanon, New Hampshire, United States
Site Status
Countries
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United States
References
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Thaker AM, Mosko JD, Berzin TM. Post-endoscopic retrograde cholangiopancreatography pancreatitis. Gastroenterol Rep (Oxf). 2015 Feb;3(1):32-40. doi: 10.1093/gastro/gou083. Epub 2014 Nov 17.
Reference Type
BACKGROUND
Neoptolemos JP, Raraty M, Finch M, Sutton R. Acute pancreatitis: the substantial human and financial costs. Gut. 1998 Jun;42(6):886-91. doi: 10.1136/gut.42.6.886.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Elmunzer BJ, Serrano J, Chak A, Edmundowicz SA, Papachristou GI, Scheiman JM, Singh VK, Varadarajulu S, Vargo JJ, Willingham FF, Baron TH, Cote GA, Romagnuolo J, Wood-Williams A, Depue EK, Spitzer RL, Spino C, Foster LD, Durkalski V; SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE). Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial. Trials. 2020 Jun 3;21(1):471. doi: 10.1186/s13063-020-04458-0.
Reference Type
BACKGROUND
Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive review. Gastrointest Endosc. 2004 Jun;59(7):845-64. doi: 10.1016/s0016-5107(04)00353-0. No abstract available.
Reference Type
BACKGROUND
Halttunen J, Meisner S, Aabakken L, Arnelo U, Gronroos J, Hauge T, Kleveland PM, Nordblad Schmidt P, Saarela A, Swahn F, Toth E, Mustonen H, Lohr JM. Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J Gastroenterol. 2014 Jun;49(6):752-8. doi: 10.3109/00365521.2014.894120. Epub 2014 Mar 14.
Reference Type
BACKGROUND
Testoni PA, Mariani A, Aabakken L, Arvanitakis M, Bories E, Costamagna G, Deviere J, Dinis-Ribeiro M, Dumonceau JM, Giovannini M, Gyokeres T, Hafner M, Halttunen J, Hassan C, Lopes L, Papanikolaou IS, Tham TC, Tringali A, van Hooft J, Williams EJ. Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016 Jul;48(7):657-83. doi: 10.1055/s-0042-108641. Epub 2016 Jun 14.
Reference Type
BACKGROUND
Haraldsson E, Kylanpaa L, Gronroos J, Saarela A, Toth E, Qvigstad G, Hult M, Lindstrom O, Laine S, Karjula H, Hauge T, Sadik R, Arnelo U. Macroscopic appearance of the major duodenal papilla influences bile duct cannulation: a prospective multicenter study by the Scandinavian Association for Digestive Endoscopy Study Group for ERCP. Gastrointest Endosc. 2019 Dec;90(6):957-963. doi: 10.1016/j.gie.2019.07.014. Epub 2019 Jul 18.
Reference Type
BACKGROUND
Haraldsson E, Lundell L, Swahn F, Enochsson L, Lohr JM, Arnelo U; Scandinavian Association for Digestive Endoscopy (SADE) Study Group of Endoscopic Retrograde Cholangio-Pancreaticography. Endoscopic classification of the papilla of Vater. Results of an inter- and intraobserver agreement study. United European Gastroenterol J. 2017 Jun;5(4):504-510. doi: 10.1177/2050640616674837. Epub 2016 Oct 17.
Reference Type
BACKGROUND
Levenick JM, Gardner TB, Hussain ZH, Gordon SR. SpyBite-assisted biliary cannulation for intradiverticular papilla during ERCP. Endoscopy. 2014;46 Suppl 1 UCTN:E514. doi: 10.1055/s-0034-1377365. Epub 2014 Nov 19. No abstract available.
Reference Type
BACKGROUND
Borahma M, Benelbarhdadi I, Berhili C, Lagdali N, Ajana FZ. Forceps-assisted technique: a new technique for difficult cannulation. Endoscopy. 2020 Jul;52(7):E247-E248. doi: 10.1055/a-1089-7418. Epub 2020 Jan 29. No abstract available.
Reference Type
BACKGROUND
Murabayashi T. The forceps-assisted technique for difficult cannulation has been in widespread use since 1996. Endoscopy. 2021 Apr;53(4):457. doi: 10.1055/a-1288-0801. Epub 2021 Mar 29. No abstract available.
Reference Type
BACKGROUND
Foster BR, Jensen KK, Bakis G, Shaaban AM, Coakley FV. Revised Atlanta Classification for Acute Pancreatitis: A Pictorial Essay. Radiographics. 2016 May-Jun;36(3):675-87. doi: 10.1148/rg.2016150097.
Reference Type
BACKGROUND
Hadley SM Jr, Chevalier JI, Tomasetti GE, Hill JC, Duclos MC, Klibansky DA, Pohl H, Siegel CA, Toor A, Bensen SP, Adler JM, Gordon SR, Gardner TB. The Effectiveness of Forceps-Assisted Cannulation for Difficult Cannulation During Endoscopic Retrograde Cholangiopancreatography: Results of the SOCCER Randomized Controlled Trial. Am J Gastroenterol. 2025 May 14. doi: 10.14309/ajg.0000000000003531. Online ahead of print.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STUDY02001449
Identifier Type: -
Identifier Source: org_study_id
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