Condition category
Digestive System
Date applied
29/10/2018
Date assigned
20/11/2018
Last edited
23/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Acute pancreatitis is a sudden inflammation of the pancreas (an organ near the stomach that produces substances that aid digestion and regulate blood sugar levels). In most cases, this inflammation is caused by gallstones, in which cases the solution is to remove the gall bladder as soon as possible, where these stones are produced. Without gall bladder removal after recovery from pancreatitis, several complications may occur, including repeated acute pancreatitis, inflammation of the gall bladder, blockage or inflammation of the bile ducts, biliary colic (sudden pain)). However, in some cases, removing the gall bladder as soon as possible can be difficult and may lead to complications. A technique called ERCP, which clears the bile ducts, can avoid these complications.
The aim of the EMILY trial is to combine a surgical treatment (removal of gall bladder) and a gastroenterological procedure (ERCP) to investigate if ERCP with delayed surgical treatment (45 to 60 days after ERCP) compared with ERCP with early surgical treatment (within 6 days after ERCP) could reduce repeated biliary events.

Who can participate?
Adults with mild gallstone-induced pancreatitis

What does the study involve?
Participants will be randomly allocated to one of two groups, group A or group B. Both groups will have their gall bladder removed, as suggested by international practice; however, the timing will differ between the two groups.
Group A is the early group and removal of the gall bladder will be performed 5-6 days after ERCP.
Group B is the delayed group and the removal of the gall bladder will be carried out within 45-60 days after ERCP.
Participants will be asked about any gallstone-related events using questionnaires during the follow-up period.

What are the possible benefits and risks of participating?
The benefit of participating is that participants will have the security and confidence that the operation will be performed on time (within 6 days or 45-60 days after ERCP). This operation is routinely performed 30 minutes last procedure; however, the waiting lists can last for up to half a year. In this study, there will be no waiting list or delays. Patients will receive attention and follow-up from health care personnel that is sadly not always ensured in regular healthcare.
The possible risk for participants in group A (early removal of gall bladder) is that the procedure may be difficult and there may be complications due to previous inflammation.
For participants in group B (delayed removal of gall bladder), there may be a higher risk for recurrent AP. However, ERCP is performed to lower this risk. If recurrent AP does develop, then participants can return to the hospital for immediate surgery.
The ERCP procedure should prevent any significant differences between groups A and B.

Where is the study run from?
University of Pécs Medical School Institute of Translational Medicine (Hungary)

When is the study starting and how long is it expected to run for?
June 2018 to May 2020

Who is funding the study?
University of Pécs Medical School (Hungary)

Who is the main contact?
Professor Péter Hegyi, Head of the Institute of Translational Medicine University of Pécs Medical School
hegyi.peter@pte.hu

Trial website

https://tm-centre.org

Contact information

Type

Scientific

Primary contact

Prof Péter Hegyi

ORCID ID

http://orcid.org/0000-0003-0399-7259

Contact details

Szigeti str. 12.
Pécs
H-7624
Hungary
+36 72 536250
hegyi.peter@pte.hu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1

Study information

Scientific title

EMILY: Endoscopic sphincterotoMy for delayIng choLecYstectomy in mild acute biliary pancreatitis

Acronym

EMILY

Study hypothesis

Cholecystectomy on admission after acute pancreatitis (AP) is difficult sometimes and may be risky to some patients. However, if the operation is delayed, the risk of recurrent AP increases. Gastroenterologists and surgeons have to decide whether to operate on patients upon admission, or to delay the surgery.
We hypothesize that carrying out an ERCP/ES early after acute pancreatitis allows us to delay cholecystectomy without increasing the risk for recurrent pancreatitis, thus making it logistically easier to perform and potentially increasing the efficacy and safety of the procedure.

Ethics approval

Ministry of Human Capacities, Chief Medical Officer of State, 18/04/2018, 11861-9/2018/EÜIG

Study design

Interventional prospective multi-centre randomised controlled trial

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No available in web format, please use contact details to request a participant information sheet.

Condition

Mild biliary pancreatitis

Intervention

Participants will be randomised by the study coordinator using a randomisation module with sealed envelope. This randomisation module will allocate the participants to the 2 different groups. Allocation will be carried out based on predefined randomisation lists created separately for each recruiting centre. The allocation sequence will be prepared with a block size of 4 and with an allocation ratio 1:1 by the Independent Data Management Board (IDMB).
This method makes it impossible for researchers to predict the allocation of the patients involved in the study. It is impossible to conceal the distribution of the patients in this study because the patients need to be scheduled for either an early cholecystectomy or a delayed cholecystectomy.
The patients are randomized to 2 groups:
1. Early cholecystectomy (within 6 days after sphincterotomy)
2. Delayed (interval) cholecystectomy (45-60 days after sphincterotomy)
There will be a follow-up 90 days after ERCP/ES.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Composite endpoint, which is based on mortality and on the following recurrent biliary events:
1. Recurrent acute biliary pancreatitis (ABP)
2. Acute cholecystitis
3. Uncomplicated biliary colic
4. Cholangitis
This will be evaluated using yes/no questions as part of a questionnaire up to 90 days after ERCP. Patients will be asked to note every biliary event using questionnaires during the 3 month follow-up observational period following ERCP.

Secondary outcome measures

The following are assessed using questionnaires and evaluation of medical records 90 days after ERCP:
1. Number of biliary colics for each patient
2. Difficult of cholecystectomy
3. Rate of conversion to cholecystectomy
4. Total length of hospital stay
5. Need for ICU admission and total length of ICU stay
6. Organ failure
7. Biliary leakage

Overall trial start date

01/06/2018

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Diagnosis of acute pancreatitis, with at least 2 of the following symptoms:
2.1. Upper abdominal pain
2.2. Serum lipase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging
2.3. Serum amylase three times higher than the upper limit of normal and characteristic findings for acute pancreatitis on imaging
3. Mild biliary pancreatitis (no pancreatic necrosis, no transient or persistent organ failure (>48 hours)) according to the revised Atlanta classification
4. Any of the following 3 definitions of biliary pancreatitis:
4.1. Diagnosis of gallstones or sludge on imaging
4.2. Dilated common bile duct on ultrasound (>8 mm in patients aged 75 years old and under, or >10 mm in patients over 75 years old) with the absence of gallstones or sludge in the gallbladder
4.3. Alanine aminotransferase level >2 times higher than normal values, with alanine aminotransferase levels greater than aspartate aminotransferase levels
5. Signed written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

89

Participant exclusion criteria

1. Poor physical status
2. American Society of Anesthesiologists (ASA) class III in patients over 75 years old
3. ASA class IV or V in patients 75 years old or younger
4. Continuous alcohol abuse
5. Chronic pancreatitis
6. Pregnancy
7. Previous sphincterotomy
8. Previous cholecystectomy

Recruitment start date

01/01/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

Hungary, Romania

Trial participating centre

University of Pecs Medical School Institute for Translational Medicine
Szigeti str 12.
Pécs
H-7624
Hungary

Trial participating centre

University of Szeged, 1st Department of Medicine
Korányi fasor 8-10.
Szeged
H-6720
Hungary

Trial participating centre

University of Debrecen
Egyetem tér 1.
Debrecen
H-4032
Hungary

Trial participating centre

Iuliu Hațieganu University of Medicine and Pharmacy Cluj-Napoca
Victor Babeș 8
Cluj-Napoca
400000
Romania

Trial participating centre

University of Medicine and Pharmacy of Targu Mures
Gheorghe Marinescu 38
Targu Mures
540139
Romania

Sponsor information

Organisation

University of Pécs

Sponsor details

Szigeti str. 12.
Pécs
H-7624
Hungary
+36 72 536 250
hegyi.peter@pte.hu

Sponsor type

University/education

Website

www.kk.pte.hu

Organisation

Hungarian Academy of Sciences, Momentum Grant

Sponsor details

Nádor str 7.
Budapest
H-1051
Hungary
+36 72 536 250
hegyi.peter@pte.hu

Sponsor type

Research organisation

Website

Organisation

GINOP 2.3.2.-15 'Stay Alive'

Sponsor details

Stigeti str 12
Pécs
H-7624
Hungary
+36 72 536 250
hegyi.peter@aok.pte.hu

Sponsor type

Research organisation

Website

Funders

Funder type

University/education

Funder name

Általános Orvostudományi Kar, Pécsi Tudományegyetem

Alternative name(s)

Medical School, University of Pécs, Medizinische Fakultät, Universität Pécs, PTE Általános Orvostudományi Kar, ÁOK, PTE, UP MS, PTE ÁOK

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Hungary

Results and Publications

Publication and dissemination plan

We plan to publish the results in a Q1 High-quality international journal.

IPD sharing statement:
The data from this study is available upon request from the principal investigators (Dezső Kelemen MD, PhD, University of Pécs, Medical School, kelemende@gmail.com and Levente-Pal Kucserik MD, UMF Targu Mures, k.levente.p@gmail.com). The questionnaires, the eCFR (raw data) and the analyzed data can be available for other laboratories by reasonable request.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/11/2018: Internal review. 21/11/2018: The recruitment start date was changed from 01/11/2018 to 01/01/2019.