Complications After Endoscopic Retrograde Cholangiopancreatography

Acute Pancreatitis Due to Gallstones Clinical Trial

— ERCP  

Official title:

Long-term Risks After Endoscopic Retrograde Cholangiopancreatography (ERCP) With Sphincterotomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735224
• Other study ID #: HMCampo2
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 20, 2020

Study information

• Verified date: January 2021
• Source: Hospital Medina del Campo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a single center retrospective study. All patients that received an ERCP with sphincterotomy for a benign disease from 1995 will be included.

The exclusion criteria are diagnosis of primary malignant tumors in the liver, bile ducts including peri-ampullary region and pancreas in the ERCP. Loss of follow-up less than two years after the ERCP and biliopancreatic malignancy diagnostic in this period. The initial work-up included laboratory test, ultrasound scan and, when precise, computed tomography (CT) and magnetic resonance image (MRI).

The data collected will be:

1. Age, sex, comorbidities, long of hospital stay.

2. ERCP indications.

3. ERCP sphincterotomy or precut, biliary stent insertion and type of stent.

4. post-ERCP diagnosis, abnormal diameter of biliary tree.

5. ERCP repetition and causes.

6. Immediate complications like bleeding, residual choledocholithiasis, ascending cholangitis, pancreatitis, and cholecystitis, and their number after more than two months.

7. Malignant complications after more than two years: cholangiocarcinoma, hepatocarcinoma and ductal pancreatic adenocarcinoma.

Stistical analyses will be performed using SPSS, ver. 25.0 (SPSS Inc., Chicago Illinois, USA). The demographics, perioperative data, operation details, length of hospital stay, morbidity, mortality and pathologic and oncological outcomes are expressed as numbers and percentages for qualitative variables and medians and interquartile ranges (IQRs) for quantitative variables.

Univariate and multivariate logistic regression analyses will be employed to determine the risk factors for the development short-term and long-term complications. Variables with P<0.1 in the univariate analysis will be further introduced into the multivariate analysis with the Wald selection method. P values < 0.05 were considered statistically significant.

This study involved the use of data from clinical records. To guarantee the proper handling of the information, the data were treated confidentially and anonymously according to the provisions of the Spanish Organic Law 15/1999, of 13 December 1999, on Personal Data Protection (LOPD). All methods were performed in accordance with the guidelines and regulations established by the Declaration of Helsinki (1964, revised in 1983) on biomedical research in humans, the Spanish Royal Decree 1090/2015, of December 4, which regulates clinical trials with drugs, the Research Ethics Committees with drugs and the Spanish Registry of Clinical Studies. Ethical approval from the Clinical Trials and Ethics Committee of Valladolid University was granted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 20, 2020
• Est. primary completion date: October 10, 2020
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juan Carlos Martín del Olmo

References & Publications (6)

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. Review. — View Citation

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. — View Citation

McCune WS, Shorb PE, Moscovitz H. Endoscopic cannulation of the ampulla of vater: a preliminary report. Ann Surg. 1968 May;167(5):752-6. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	association between ERCP with sphincterotomy and the development of neoplasm in the bile ducts	risks of malignancy	10 years
Primary	long-term complications after ERCP with sphincterotomy	Long- terms complications registered	10 years
Secondary	characteristics of patients who develop complications after endoscopy sphincterotomy	defined characteristics	10 years