Complications After Endoscopic Retrograde Cholangiopancreatography

NCT04735224 | Completed DMC

• 1 other identifier: HMCampo2
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retrospective study to analyze benign complications and malignancy risks after ERCP with sphincterotomy. All patients who received a ERCP with sphincterotomy for a benign disease will be included. Post-ERCP hepato-biliary complications in the follow-up will be registered.

Conditions

Choledocholithiasis With Acute Cholangitis (Diagnosis); Acute Pancreatitis Due to Gallstones

Keywords

ERCP; ERCP complications; Endoscopic Sphincterotomy

Outcome Measures

Primary Outcomes (1)

• long-term complications after ERCP with sphincterotomy

  Long- terms complications registered

  10 years

Secondary Outcomes (1)

• characteristics of patients who develop complications after endoscopy sphincterotomy

  10 years

Other Outcomes (1)

• association between ERCP with sphincterotomy and the development of neoplasm in the bile ducts

  10 years

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015

You may qualify if:

• Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015

You may not qualify if:

• Diagnosis of primary malignant tumors in the liver, bile ducts including ampullary region, and pancreas in the ERCP test.
• Patients with follow-up less than two years after the ERCP and biliopancreatic malignancy diagnostic in this period.

Sponsors & Collaborators

• Juan Carlos Martín del Olmo: lead

Related Publications (6)

• McCune WS, Shorb PE, Moscovitz H. Endoscopic cannulation of the ampulla of vater: a preliminary report. Ann Surg. 1968 May;167(5):752-6. doi: 10.1097/00000658-196805000-00013. No abstract available.

  PMID: 5646296 BACKGROUND

• Nakajima M, Kimoto K, Fukumoto K, Ikehara H, Kawai K. Endoscopic sphincterotomy of the ampulla of Vater and removal of common duct stones. Am J Gastroenterol. 1975 Jul;64(1):34-43. No abstract available.

  PMID: 1155423 BACKGROUND

• Oliveira-Cunha M, Dennison AR, Garcea G. Late Complications After Endoscopic Sphincterotomy. Surg Laparosc Endosc Percutan Tech. 2016 Feb;26(1):1-5. doi: 10.1097/SLE.0000000000000226.

  PMID: 26679684 BACKGROUND

• ASGE Standards of Practice Committee; Chathadi KV, Chandrasekhara V, Acosta RD, Decker GA, Early DS, Eloubeidi MA, Evans JA, Faulx AL, Fanelli RD, Fisher DA, Foley K, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf R, Shaukat A, Shergill AK, Wang A, Cash BD, DeWitt JM. The role of ERCP in benign diseases of the biliary tract. Gastrointest Endosc. 2015 Apr;81(4):795-803. doi: 10.1016/j.gie.2014.11.019. Epub 2015 Feb 7. No abstract available.

  PMID: 25665931 BACKGROUND

• 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.

  PMID: 27546389 BACKGROUND

• Sung JY, Leung JW, Shaffer EA, Lam K, Olson ME, Costerton JW. Ascending infection of the biliary tract after surgical sphincterotomy and biliary stenting. J Gastroenterol Hepatol. 1992 May-Jun;7(3):240-5. doi: 10.1111/j.1440-1746.1992.tb00971.x.

  PMID: 1611012 BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Carlos Martin Del Olmo, MD, PhD

  Hospital Medina del Campo

  STUDY DIRECTOR

• Mercedes Ibáñez García, MD, PhD

  Hospital Medina del Campo

  PRINCIPAL INVESTIGATOR

• Carlos Guijarro, MD, PhD

  Hospital Medina del Campo

  STUDY CHAIR

• Kostantin Shirai, MD, PhD

  Hospital Medina del Campo

  STUDY CHAIR

• Cristina López Mestanza, MD, PhD

  Hospital Medina del Campo

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD. Associate Profesor Valladolid University

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: February 3, 2021
• Study Start: January 1, 2017
• Primary Completion: October 10, 2020
• Study Completion: December 20, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01