Choledocholithiasis With Acute Cholangitis (Diagnosis)ERCPNCT04735224
Complications After Endoscopic Retrograde Cholangiopancreatography
An observational study of Choledocholithiasis With Acute Cholangitis (Diagnosis) and Acute Pancreatitis Due to Gallstones, run by Juan Carlos Martín del Olmo.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choledocholithiasis With Acute Cholangitis (Diagnosis), Acute Pancreatitis Due to Gallstones
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 20 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015
Who may be able to join
- Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015
Who cannot join
- 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.
About this study
Official title: Long-term Risks After Endoscopic Retrograde Cholangiopancreatography (ERCP) With Sphincterotomy.
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.
Read the 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:
- Age, sex, comorbidities, long of hospital stay.
- ERCP indications.
- ERCP sphincterotomy or precut, biliary stent insertion and type of stent.
- post-ERCP diagnosis, abnormal diameter of biliary tree.
- ERCP repetition and causes.
- Immediate complications like bleeding, residual choledocholithiasis, ascending cholangitis, pancreatitis, and cholecystitis, and their number after more than two months.
- 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.
- Conditions
- Choledocholithiasis With Acute Cholangitis (Diagnosis), Acute Pancreatitis Due to Gallstones
- Keywords
- ERCP, ERCP complications, Endoscopic Sphincterotomy
- Medical subject headings
- Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
long-term complications after ERCP with sphincterotomy
Long- terms complications registered
Measured: 10 years
Secondary outcomes (1)
characteristics of patients who develop complications after endoscopy sphincterotomy
defined characteristics
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Jan 2017
- Primary completion10 Oct 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Choledocholithiasis With Acute Cholangitis (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Carlos Martín del Olmo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Carlos Martín del Olmo, Hospital Medina del Campo
- Investigators
- Juan Carlos Martin Del Olmo, MD, PhD, Study director, Hospital Medina del CampoMercedes Ibáñez García, MD, PhD, Principal investigator, Hospital Medina del CampoCarlos Guijarro, MD, PhD, Study chair, Hospital Medina del CampoKostantin Shirai, MD, PhD, Study chair, Hospital Medina del CampoCristina López Mestanza, MD, PhD, Study chair, Hospital Medina del Campo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735224
- Sponsor's protocol ID
- HMCampo2
- Acronym
- ERCP
- Status last verified
- Jan 2021
- First submitted
- 22 Dec 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 5646296Nakajima 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.
PubMed 1155423Oliveira-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.
PubMed 26679684ASGE 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.
PubMed 25665931ASGE 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.
PubMed 27546389Sung 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.
PubMed 1611012
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Risks After Endoscopic Retrograde Cholangiopancreatography (ERCP) With Sphincterotomy.
- ClinicalTrials.gov ID
- NCT04735224
- Acronym / sponsor ID
- ERCP / HMCampo2
- Conditions
- Choledocholithiasis With Acute Cholangitis (Diagnosis), Acute Pancreatitis Due to Gallstones
- Keywords
- ERCP, ERCP complications, Endoscopic Sphincterotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Juan Carlos Martín del OlmoUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Age, sex, comorbidities, long of hospital stay.
- ERCP indications.
- ERCP sphincterotomy or precut, biliary stent insertion and type of stent.
- post-ERCP diagnosis, abnormal diameter of biliary tree.
- ERCP repetition and causes.
- Immediate complications like bleeding, residual choledocholithiasis, ascending cholangitis, pancreatitis, and cholecystitis, and their number after more than two months.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015
Key inclusion criteria (1 listed)
- Patients having undergone ERCP with sphincterotomy for benign diseases between 1995 and 2015
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
long-term complications after ERCP with sphincterotomy
Time frame: 10 years
Long- terms complications registered
1 secondary outcome
characteristics of patients who develop complications after endoscopy sphincterotomy
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Background: PubMed 5646296McCune 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.
- Background: PubMed 1155423Nakajima 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.
- Background: PubMed 26679684Oliveira-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.
- Background: PubMed 25665931ASGE 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.
- Background: PubMed 27546389ASGE 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.
- Background: PubMed 1611012Sung 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.
- Individual participant dataSharing planned: Undecided
Related trials for Choledocholithiasis With Acute Cholangitis (Diagnosis)
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Modified Laparoscopic Transcystic Biliary Drainage in the Management of Cholecystocholedocholithiasis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos Martin Del Olmo, MD, PhD study director
Hospital Medina del Campo
Mercedes Ibáñez García, MD, PhD principal investigator
Hospital Medina del Campo
Carlos Guijarro, MD, PhD study chair
Hospital Medina del Campo
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis With Acute Cholangitis (Diagnosis) and Acute Pancreatitis Due to Gallstones, run by Juan Carlos Martín del Olmo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-term complications after ERCP with sphincterotomy (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04735224, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.