How long to wait before operating on the gall bladder after gallstone-induced acute pancreatitis?
| ISRCTN | ISRCTN10667869 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10667869 |
| Secondary identifying numbers | V1 |
- Submission date
- 29/10/2018
- Registration date
- 20/11/2018
- Last edited
- 14/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 discharge) compared with ERCP with early surgical treatment (within 6 days after discharge) 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 6 days after discharge.
Group B is the delayed group and the removal of the gall bladder will be carried out within 45-60 days after discharge.
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 discharge). 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 2025 (updated 14/11/2019, previously: 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
Contact information
Scientific
Szigeti str. 12.
Pécs
H-7624
Hungary
 ORCID ID |
0000-0003-0399-7259 |
|---|---|
| Phone | +36 72 536250 |
| hegyi.peter@pte.hu |
Study information
| Study design | Interventional prospective multi-centre randomised controlled trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No available in web format, please use contact details to request a participant information sheet. |
| Scientific title | EMILY: Endoscopic sphincterotoMy for delayIng choLecYstectomy in mild acute biliary pancreatitis |
| Study acronym | EMILY |
| Study objectives | 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 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(s) | Ministry of Human Capacities, Chief Medical Officer of State, 18/04/2018, 11861-9/2018/EÜIG |
| Health condition(s) or problem(s) studied | 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 discharge) 2. Delayed (interval) cholecystectomy (45-60 days after discharge) There will be a follow-up 90 days after discharge |
| Intervention type | Procedure/Surgery |
| 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 discharge. Patients will be asked to note every biliary event using questionnaires during the 3 month follow-up observational period following discharge. |
| Secondary outcome measures | The following are assessed using questionnaires and evaluation of medical records 90 days after discharge: 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 study start date | 01/06/2018 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 89 |
| Key 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. ERCP/ES either during the index admission or in the medical history without complication (added 01/02/2019) 6. Signed written informed consent |
| Key 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 (removed 01/02/2019) 8. Previous cholecystectomy |
| Date of first enrolment | 01/03/2019 |
| Date of final enrolment | 31/10/2024 |
Locations
Countries of recruitment
- Hungary
- Romania
Study participating centres
Pécs
H-7624
Hungary
Szeged
H-6720
Hungary
Debrecen
H-4032
Hungary
Cluj-Napoca
400000
Romania
Targu Mures
540139
Romania
Sponsor information
University/education
Szigeti str. 12.
Pécs
H-7624
Hungary
| Phone | +36 72 536 250 |
|---|---|
| hegyi.peter@pte.hu | |
| Website | http://aok.pte.hu |
Research organisation
Nádor str 7.
Budapest
H-1051
Hungary
| Phone | +36 72 536 250 |
|---|---|
| hegyi.peter@pte.hu |
Research organisation
Stigeti str 12
Pécs
H-7624
Hungary
| Phone | +36 72 536 250 |
|---|---|
| hegyi.peter@aok.pte.hu |
Not defined
| Website | http://pte.hu/english |
|---|---|
"ROR" |
https://ror.org/037b5pv06 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Medizinische Fakultät, Universität Pécs, PTE Általános Orvostudományi Kar, Medizinische Fakultät, Universität Pécs, Medical School, University of Pécs, ÁOK, PTE, UP MS, PTE ÁOK
- Location
- Hungary
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We plan to publish the results in a Q1 High-quality international journal. |
| IPD sharing plan | 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. |
Editorial Notes
14/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/10/2019 to 31/10/2024.
2. The overall end date was changed from 31/05/2020 to 31/05/2025.
3. The intention to publish date was changed from 31/12/2020 to 31/12/2025.
4. The plain English summary was updated to reflect these changes.
5. The sponsor website was changed from www.kk.pte.hu to http://aok.pte.hu.
01/02/2019: The inclusion and exclusion criteria were updated.
25/01/2019: Internal review.
23/01/2019: The recruitment start date was changed from 01/01/2019 to 01/03/2019.
23/11/2018: Internal review.
21/11/2018: The recruitment start date was changed from 01/11/2018 to 01/01/2019.
