Complications of Endoscopic Retrograde Cholangiopancreatography (ERCP)

Not yet recruiting

Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

Registration Number: CTRI/2019/01/017161

Lead Sponsor: Abhinav Kumar

Brief Summary: **INTRODUCTION:**

Endoscopic retrograde cholangiopancreatography (ERCP) is a form of endoscopy where a Side-viewing endoscope is introduced into the duodenum, following which instruments are passed into bile or pancreatic ducts, to allow their radiological visualisation by injecting contrast medium and/or perform various therapeutic procedures, e.g., removal of bile duct stone. It is a complex endoscopic procedure with long learning curve and has number of complications which can even be life-threatening. Since its introduction in 1968, ERCP has become a widely used endoscopic procedure for a variety of disorders.. Endoscopic biliary sphincterotomy was first reported in 1974. ERCP at its inception was predominantly a diagnostic procedure, however over the past decade its predominantly carried out for therapeutic indications because of the availability of other imaging techniques, such as abdominal Ultrasound (US), Computed Tomography (CT), Magnetic resonance cholangiopancreatography (MRCP), Endoscopic Ultrasound (EUS) that provide detailed diagnostic information and thus allowing appropriate selection of patients for therapeutic ERCP.

Complications are expected to occur in a proportion of patients undergoing ERCP, even when performed by endoscopists with significant expertise in the procedure. A number of patient-related and technique-related factors are known to increase the risk of complication. ERCP requires sedation and therefore has in addition a risk of anaesthesia related adverse events Most of the complications post-ERCP are apparent during the first 6 hours after the procedure. Thus patients require careful monitoring during this phase to detect symptoms or signs suggesting adverse events.

Table 1 below sums up the complications related to ERCP that has been reported in various studies

| | |

| --- | --- |

|Related to pancreaticobiliary instrumentation

Pancreatitis

Bleeding

Infection

|Related to technical issue with endoscopy

Electrosurgical hazards:

Thermal injury: perforation

Inadequate cautery: Bleeding

Air insufflation: Post ERCP pain

Contrast allergy

Perforation

|Related to anesthesia

Cardiopulmonary complication:

Aspiration

Hypoxemia

Cardiac dysrhythmia

|Rare complications

Gallstone ileus

Colonic perforation

Liver abscess

splenic/hepatic/vascular trauma

Pneumothorax

Gas embolism

Impaction of retrieval basket

Biloma

Table 1: Complications of ERCP

Multiple studies have evaluated the incidence of post ERCP complications . Prospective surveys from single referral centres ensure the highest accuracy but are unlikely to be representative of the frequency and severity of unfavourable events in day-to-day practice. By comparison, prospective multi-centre studies involving centres with different volumes of activity and operators with various degrees of expertise more reliably reflect the general effectiveness and safety of ERCP in the community..

There are no large scale study evaluating the complications of ERCP in Indian or even Asian population. In an attempt to address this deficit we will be conducting a dual centre prospective study to look at the incidence of various ERCP-related complications. Proposed study will be done in both a tertiary care public academic centre and a tertiary-care private hospital. Both have specialised and well equipped department to carry out ERCP procedures and evaluate and manage complications if any.

**AIMS:**

**Primary Aim:**

To evaluate incidence of complications of diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

**Secondary Aim:**

To identify possible risk factors for these complications.

**DEFINITIONS:**

- ERCP Procedure: Defined as a procedure when the endoscopist has made contact, persistently or repeatedly, with the major (or minor) papilla with an intention to cannulate the bile duct and/or pancreatic duct for diagnostic or therapeutic purpose. Intended ERCP, where the endoscopist makes contact with papillae but fails to cannulate will be taken as an ERCP procedure.

- COMPLICATION: An unplanned event attributable to the ERCP procedure that requires the patient to be admitted to hospital, or to stay longer than expected, or to undergo other interventions

- Within 30 days of procedure

- We do not count in complication statistics any deviation that occurs during a procedure that is not obvious to the patient afterwards, and does not require unplanned admission.

- INCIDENTS â€“ Undesired events that do not qualify as complications.

- ADVERSE SEQUELAE â€“ Adverse but inevitable results of the procedure, such as the loss of sphincter activity due to sphincterotomy.

**Study Area:**

1. School of Digestive and Liver Diseases, IPGME&R and SSKM Hopsital, Kolkata

2. Department of Gastroenterology, AMRI Hospitals, Salt Lake, Kolkata

**Study Design:**

Prospective non randomised study

**Study Plan:**

There will be 2 structured proformas to collect the data and detailed records will be taken as per proforma designed.

Proforma 1: Procedural details will be recorded by the endoscopist performing ERCP.

Proforma 2: This will be divided into 4 parts and the investigator will collect data. The collected data will involve:

- Preprocedural data

- Procedural data

- Post procedure follow up questionnaire

- Complications (if any) and grading of severity of complication

This will be filled up by the investigator at differing time points as below:

- On the day of ERCP

- During follow up at 24 hrs, 48 hrs, 1 week and 30 days by telephonic interviews, review of available medical records (for inpatients) and by face-to-face interview (for out-patients)

- If patient admitted, theyâ€™ll be managed by the attending physician as per their discretion. However, the management data and investigations performed will be recorded in Proforma 2

**Study tools:**

- Analysis of previous medical and interventional records.

- Platelet count

- PT/INR

- CBC/PCV (if clinically indicated)

- Amylase/Lipase (if clinically indicated)

- Ultrasonography/ CT scan/ MRCP/ERCP (if clinically indicated)

- X ray (if clinically indicated)

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 2200

Inclusion Criteria

Those more than or equal to 12 years of age undergoing diagnostic or therapeutic ERCP between 1st June 2018 to 31st November 2019 either for the first time or after a previous failed cannulation attempt.

Exclusion Criteria

A)Surgically altered anatomy of Upper GI tract B)Failure of endoscopist to reach second part of duodenum due to pyloro-duodenal obstruction despite endoscopic attempts to relieve the obstruction (e.g., balloon dilatation of stricture).
C)Those undergoing side-viewing endoscopy only with or without ampullary biopsy D)Those undergoing stent removal without any biliary/pancreatic endotherapy E)Repeat biliary endotherapy (e.g., stent exchange, second attempt at difficult stone removal) without pancreatic endotherapy F)Repeat pancreatic endotherapy without biliary endotherapy G)Immunodeficiency (primary or secondary) H)Pregnancy.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication is defined as:	Upto 30 days Post ERCP
.	Upto 30 days Post ERCP
An unplanned event attributable to the ERCP procedure that requires the patient to be admitted to hospital, or to stay longer than expected, or to undergo other interventions	Upto 30 days Post ERCP
To evaluate incidence of complications of diagnostic and therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)	Upto 30 days Post ERCP
Within 30 days of procedure	Upto 30 days Post ERCP
We do not count in complication statistics any deviation that occurs during a procedure and does not require unplanned admission.	Upto 30 days Post ERCP

Secondary Outcome Measures

Name	Time	Method
To identify possible risk factors for these complications.	30 days

Trial Locations

Locations (1): Department of Gastroenterology
🇮🇳
Kolkata, WEST BENGAL, India
Department of Gastroenterology
🇮🇳Kolkata, WEST BENGAL, India
Dr Abhinav Kumar
Principal investigator
8377887254
abhinavkumarshah@gmail.com