Clinical trial NCT04735224: Complications After Endoscopic Retrograde Cholangiopancreatography
Official title: Long-term Risks After Endoscopic Retrograde Cholangiopancreatography (ERCP) With Sphincterotomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis With Acute Cholangitis (Diagnosis)
Acute Pancreatitis Due to Gallstones
Keywords: ERCP
ERCP complications
Endoscopic Sphincterotomy
Lead sponsor: Hospital Medina del Campo
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: long-term complications after ERCP with sphincterotomy
timeFrame: 10 years
Secondary outcomes:
measure: characteristics of patients who develop complications after endoscopy sphincterotomy
timeFrame: 10 years
Other outcomes:
measure: association between ERCP with sphincterotomy and the development of neoplasm in the bile ducts
timeFrame: 10 years
Locations:
Study officials:
affiliation: Hospital Medina del Campo
name: Juan Carlos Martin Del Olmo, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Medina del Campo
name: Mercedes Ibáñez García, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Medina del Campo
name: Carlos Guijarro, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Medina del Campo
name: Kostantin Shirai, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Medina del Campo
name: Cristina López Mestanza, MD, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1097/00000658-196805000-00013. No abstract available.
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. No abstract available.
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.
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. No abstract available.
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.
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. doi: 10.1111/j.1440-1746.1992.tb00971.x.