Informed Consent for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Section 1info grid
Section 2text block
Section 3list block
Section 4list block
Section 5text block
Section 6list block
Section 7text block
Section 8text block
Section 9text block
Section 10text block
Section 11text block
Section 12text block
Section 13text block
Section 14text block
Section 15signature block

Informed Consent for Endoscopic Retrograde Cholangiopancreatography (ERCP)

Patient and Procedure Information

Nature and Purpose of the Procedure

Endoscopic Retrograde Cholangiopancreatography (ERCP) is an advanced specialized procedure used to examine and treat conditions of the bile ducts and pancreatic ducts. An endoscope is passed through your mouth, esophagus, and stomach into the duodenum. A small plastic tube (catheter) is then threaded through the scope and into the opening where the bile and pancreatic ducts drain (the papilla). A liquid contrast dye is injected, and X-ray images (fluoroscopy) are taken to visualize stones, blockages, or narrow areas. If abnormalities are found, therapeutic interventions may be performed during the same procedure: (1) Sphincterotomy: cutting the small muscle of the duct opening to allow stones to pass or improve drainage, (2) Stone extraction: using a balloon or basket to pull stones from the duct, (3) Stent placement: inserting a plastic or metal mesh tube to keep a narrowed duct open, (4) Biopsy or brush cytology: collecting cells or tissue samples for analysis.

Therapeutic Intervention Authorizations

I authorize the physician to perform a sphincterotomy (cutting the muscle opening of the bile/pancreatic duct) if needed to extract stones or place drainage stents.
I authorize the placement of temporary or permanent biliary or pancreatic stents (plastic or metal mesh tubes) to relieve duct blockages.
I authorize the removal or replacement of existing stents if present.
I authorize tissue biopsies, fluid aspirations, or brush cytology for diagnostic pathology analysis.

Material Risks and Potential Complications

Post-ERCP Pancreatitis: inflammation of the pancreas, which is the most common complication of ERCP. It occurs in 5 to 10 percent of patients. While most cases are mild and resolve with 2 to 3 days of hospitalization, severe pancreatitis can lead to organ failure, prolonged intensive care, or death. The physician may place a pancreatic stent or administer rectal medication at the end of the procedure to reduce this risk.
Infection (Cholangitis/Cholecystitis): infection of the bile ducts or gallbladder can occur if bile drainage is not fully restored. Antibiotics are given before and sometimes after the procedure to reduce this risk.
Bleeding: occurs in 1 to 2 percent of cases, almost always related to a sphincterotomy cut. It is usually controlled during the procedure, but delayed bleeding can occur up to 2 weeks later, requiring hospital admission or a blood transfusion.
Perforation: a tear or hole in the esophagus, stomach, duodenum, or bile duct. This occurs in less than 1 percent of cases. A perforation is a serious complication that often requires immediate surgical intervention to repair.
Radiation exposure: the procedure uses X-ray imaging. The dose of radiation is kept as low as possible. Female patients must report if there is any chance of pregnancy.
Sedation and anesthesia risks: breathing problems, drop in blood pressure, or adverse drug reactions. Anesthesia providers monitor your vitals continuously.

Surgical Backup Acknowledgment

Because ERCP is an invasive therapeutic procedure, serious complications such as perforation, uncontrolled bleeding, or severe infection can occur. I understand that if a complication arises that cannot be managed endoscopically, emergency transfer to a surgical team and immediate abdominal surgery (laparotomy) may be required. I authorize the clinical team to initiate such emergency measures if determined necessary to preserve my safety.

Alternatives to ERCP

Magnetic Resonance Cholangiopancreatography (MRCP): a non-invasive MRI scan of the ducts. Can diagnose issues but cannot perform therapeutic actions (e.g. cannot remove stones).
Endoscopic Ultrasound (EUS): a specialized endoscope using sound waves to view the ducts from inside the stomach. Used for diagnosis; cannot perform most duct interventions.
Percutaneous Transhepatic Cholangiography (PTC): a radiologist inserts a needle through the skin of your abdomen into the liver to drain bile or clear stones. An alternative if ERCP cannot be completed.
Open or laparoscopic surgery: direct surgical exploration and clearing of the bile ducts.

Pre-Procedure Requirements

You must not eat any solid food for at least 8 hours and must not drink clear liquids for at least 4 hours before the procedure. You must tell your doctor about all blood thinners (aspirin, Plavix, Coumadin, Eliquis) you take. These must be stopped for a specified number of days before the procedure to minimize bleeding risks during sphincterotomy.

Post-Procedure Warning Signs

You must seek immediate emergency medical care if you experience: (1) Severe, sharp, or worsening pain in your abdomen or back, (2) Fever or chills, (3) Nausea and vomiting that does not stop, (4) Black, tarry stools or blood in your stool, (5) Dizziness, fainting, or weakness, (6) Yellowing of your skin or eyes (jaundice).

Discharge Driver Requirement

You will receive deep sedation or general anesthesia. You are required to have a responsible adult driver accompany you to the facility, remain during the procedure, and drive you home. You must not drive or make critical decisions for 24 hours after the procedure.

Right to Withdraw Consent

You have the right to refuse the ERCP procedure. The physician will discuss the risks of untreated duct blockages, which include severe infection (cholangitis), liver damage, pancreatitis, and worsening jaundice.

Patient Understanding and Questions

I confirm that I have read this document and understand the ERCP procedure, its benefits, risks, and alternatives. I have had my questions answered to my satisfaction. I understand that ERCP has specific risks, including pancreatitis and perforation, and I consent to proceed.

Language Access

If English is not your primary language, a qualified medical interpreter is available to assist you at no cost. Please notify the facility before signing.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this consent form.

Patient Authorization

I voluntarily consent to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) and the therapeutic interventions (sphincterotomy, stone extraction, stent placement, or biopsy) determined necessary by the physician. I confirm I have followed all pre-procedure fasting and medication guidelines.

Signatures and Verification

Patient / LAR Signature
Gastroenterologist Signature
Witness Signature
Date and Time of Consent
Document ID: CC-PENDING
CONSENTCOLLECT