Definitions: INDIEH Trial

A
ASGE: American Society of Gastrointestinal Endoscopy
Adverse events: If time window not specified in the adverse event form, 30 day follow-up
period should be considered for reporting adverse events.
Acute pancreatitis: Acute pancreatitis is an acute inflammatory process of the pancreas. Acute
pancreatitis should be suspected in patients with severe acute upper abdominal pain but requires
biochemical or radiologic evidence to establish the diagnosis.
Atlanta Classification:
The diagnosis of acute pancreatitis requires two of the following three features: (1)
abdominal pain consistent with acute pancreatitis (acute onset of a persistent, severe,
epigastric pain often radiating to the back); (2) serum lipase activity (or amylase activity)
at least three times greater than the upper limit of normal; and (3) characteristic findings
of acute pancreatitis on contrast-enhanced computed tomography (CECT) and less
commonly magnetic resonance imaging (MRI) or transabdominal ultrasonography.

Sleisenger 9th Edition:

Acute pancreatitis is best defined clinically by a patient presenting with two of the following
criteria:

Symptoms, such as epigastric pain, consistent with the disease

A serum amylase or lipase greater than three times the upper limit of normal
Radiologic imaging consistent with the diagnosis, usually using computed
tomography (CT) or magnetic resonance imaging (MRI)

Ampullectomy:
Endoscopic ampullectomy is a minimally invasive method of treating superficial lesions of the
ampulla of Vater.
(Bassan, Milan, and Michael Bourke. "Endoscopic ampullectomy: a practical guide." Journal of interventional gastroenterology
2.1 (2012): 23-30.)

Active or recent gastrointestinal hemorrhage (within 7 days before ERCP)

Amylase levels:

The reference range of serum amylase is with respect to each individual site. The reference range
may change at different sites.
Anticipated inability to follow protocol
Arrythmias:

NIH definition:
An arrhythmia is a problem with the rate or rhythm of the heartbeat. During an arrhythmia, the
heart can beat too fast, too slow, or with an irregular rhythm.
A heartbeat that is too fast is called tachycardia. A heartbeat that is too slow is called
bradycardia.

B
Balloon Dilation:
ASGE patient information:
There are ERCP catheters fitted with dilating balloons that can be placed across a narrowed area
or stricture. The balloon is then inflated to stretch out the narrowing. Dilation with balloons is
often performed when the cause of the narrowing is benign (not a cancer). After balloon dilation,
a temporary stent may be placed for a few months to help maintain the dilation.
Biliary type pain:
1.
2.
3.
4.
5.

Episodes last longer than 30 min;

Pain builds up to a steady level;
Pain is severe enough to disrupt daily activities or lead to an emergency department visit;
Pain is not relieved by defecation, charge in position, or acid suppression;
No other structural abnormalities that would explain the pain.

C
Cannulation attempt: Any contact with the papilla will be considered an attempt to cannulate,
as defined by the endoscopist.
Cannulation time: Total time from the start of first attempt to cannuate to either successful
cannulation or being considered as failed cannulation
Chronic Pancreatitis: Calcifications must be identified in any form of imaging, non-calcific
chronic pancreatitis cannot be considered as exclusion criteria
Consent form: It is not mandatory to follow the consent form provided by Hokpins for the
Indian sites. They can use their own consent forms which are authentic and valid.

If they do not follow any authentic schedule or form and just make manual changes to the
Hopkins consent form, then the respective site coordinator has to first get it checked with the
authority at Hopkins before using it.
Criteria for high risk: Please verify the High risk criteria

D
E
ERCP:
ASGE definition of ERCP for patients:
Endoscopic Retrograde CholangioPancreatography, or ERCP, is a specialized technique used to
study the bile ducts, pancreatic duct and gallbladder. Ducts are drainage routes; the drainage
channels from the liver are called bile or biliary ducts. The pancreatic duct is the drainage
channel from the pancreas.
ERCP for biliary stent removal or exchange without anticipated pancreatogram: If any of
the procedure related major/minor inclusion criteria is met, even if patient is here for biliary stent
exchange, patient can be included
Evidence of over bleeding: Refer Over bleeding
Evidence of Hypertension: Refer Hypertension
Evidence of arrhythmias after ERCP: Refer Arrhythmias

F
G
Guide wire: Whether guide wire was used to assist in cannulation

H
High risk criteria:
Hematemesis: Refer Over bleeding
Hematochezia: Refer Over bleeding
Hypertension:

Intravenous Fluid: List the total volume and type of fluid given
Irritable Bowel Syndrome: Rome III diagnostic criteria* for irritable bowel syndrome Recurrent abdominal pain or discomfort at least 3 days per month in the last 3 months associated
with 2 or more of the following:
(1) Improvement with defecation
(2) Onset associated with a change in frequency of stool
(3) Onset associated with a change in form (appearance) of stool
* Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Discomfort means an uncomfortable sensation not described as pain. In pathophysiology
research and clinical trials, a pain/discomfort frequency of at least 2 days a week during
screening evaluation for subject eligibility.
Intervention (surgical, radiologic, or endoscopic) to manage complications of ERCP: List
only these interventions if performed on complications of ERCP such as pancreatitis, perforation,
hemorrhage etc.
Initials: Write only initials of ERCPist and coordinator but record the full name in another
location for your own reference

J
Juxtapapillary diverticula: A small outpouching commonly situated on the second part of the
duodenum easily visualized during ERCP

K
L
M
Medications: List all medications received by the patient within 6 hrs after ERCP. Can be free
text. (List in Form 4)
Melena: Refer Over bleeding
Myocardial Infarction:

N
NSAIDs given in prior 3 days: Aspirin need not be considered as an exclusion criteria. Some
of common NSAIDs to be considered ibuprofen, naproxen, indomethacin, ketorolac,
mefenamic acid, aceclofenac, nimesulide

Over bleeding: Any over bleeding through mouth or anus (gastrointestinal bleed)

Lippincott Williams: Clinical Methods: The History, Physical, and Laboratory

Examinations. 3rd edition.
Hematemesis: It is the vomiting of blood, which may be obviously red or have an appearance
similar to coffee grounds. Hematemesis indicates that the bleeding is from the upper
gastrointestinal tract, usually from the esophagus, stomach, or proximal duodenum.
NB: Occasionally hemoptysis or vomiting of swallowed blood from epistaxis can be confused
with hematemesis. A careful history usually resolves this confusion. Hemoptysis is associated
with coughing and is bright, foamy red in color. The patient with profuse epistaxis is almost
invariably aware that a nosebleed has occurred.
Melena: It is the passage of black, tarry stools. Make the patient understand that you mean jet
black by comparing the stool color to a black object. Melenic stools also have a stickiness that
the patient often remembers.
A melenic stool usually means upper gastrointestinal hemorrhage, whereas hematochezia
usually has a colonic (large intestine) source.
Hematochezia: It is the passage of fresh blood per anus, usually in or with stools.

P
Pancreatic necrosis:

Sleisenger 9th Edition:

Necrotizing pancreatitis is defined, in the absence of laparotomy or autopsy, by the presence of
greater than 30% of nonenhancement of the pancreas on a contrast-enhanced CT scan.

Definition on UptoDate.com: (Walled off pancreatic necrosis)

Heterogenous fluid collection with liquid and non-liquid density, with varying degrees of
loculation
A well-defined wall that completely encapsulates the fluid collection
Intrahepatic and/or extrahepatic location

Pancreatic pseudocyst:

Sleisenger 9th Edition:

A pseudocyst may occur secondary to acute pancreatitis, pancreatic trauma, or chronic

pancreatitis. It usually contains a high concentration of pancreatic enzymes and variable amounts
of tissue debris

Definition on UptoDate.com :
Pseudocysts represent more mature fluid collections also outside the pancreas (typically
developing at least four weeks after acute pancreatitis), have a well-defined wall, and again there
should be no solid material or pancreatic necrosis present. Pseudocysts may also develop
following pancreatic trauma.
Findings on cross sectional imaging include:

A well-circumscribed fluid collection that is usually round or oval

The fluid collection is typically extrahepatic
Homogenous fluid density
No non-liquid components within the fluid
A well-defined wall that completely encapsulates the fluid collection

Post-ERCP pancreatitis Definition: (Must meet all criteria below)

1) New or increased abdominal pain that is clinically consistent with a syndrome of acute
pancreatitis and 2) amylase or lipase 3x the upper limit of normal 24 hours after the procedure
and 3) Hospitalization or prolongation of existing hospitalization for at least 2 days.
Pancreatic stent: If patient required pancreatic duct stent to be placed for any reason, during
ERCP, patient will be excluded.

Prior biliary sphincterotomy, now scheduled for biliary therapy without pancreatogram:
Please note that extension of prior sphincterotomy will be considered new sphincterotomy. New
biliary sphincterotomy without pancreatogram is not an exclusion criteria.
Pancreatic acinarization: Acinarization was defined as any fluoroscopically observed focal or
diffuse pancreatic parenchymal blush of contrast.
Pre sphincterotomy: An incision is made on the papilla prior to free cannulation and/or wire
guidance.
Pancreatic Brush Cytology:
Brush in this context means a specialized tiny brush attached to the tip of an endoscopic
equipment.
Cytology is a type of cellular diagnostic technique that uses microscopy to diagnose the
pathological conditions.
Pancreatic brush cytology means a specimen is drawn by brushing from the pancreatic duct with
the help of the pancreatic brush through endoscopy. This specimen is then analysed n=by a
pathologist under microscope.

Pre- procedural abdominal pain: This is the level of pain which the patient mentions. It is
subjective and based on the patient`s response to our question of how much pain is he/ she
experiencing then.
Pancreatic sphincterotomy: New sphincterotomy or extension of previous sphincterotomy
Pneumatic dilation of an intact sphincter: Dilating sphincter using balloon without
pancreatic/biliary sphincterotomy
Pancreatic injections: Injecting pancreatic duct
Pancreatic Brush Cytology: A brush catheter is passed through the endoscope and plunged
into the pancreatic duct five to ten times. The brush is then retracted and the specimen is
extruded onto glass slides or into a preservative medium
Pancreatic head mass: As it constricts and atrophies the pancreatic duct so risk of Post ERCP
pancreatitis is reduced.
Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas
divisum (dorsal duct not attempted or injected): Pancreas divisum refers to two pancreatic
ductal systems that do not unite during embryologic organogenesis and drain separately via the
two duodenal papillaethe dominant dorsal system through the minor papilla and the smaller
ventral system through the major papilla. Since dorsal duct is the dominant draining duct, so if
its not cannulated, the patient is not at risk of developing pancreatitis.

Prior cholecystectomy: Already surgically removed gallbladder

Pancreaticobiliary malignancy: Cholangiocarcinoma, Ampullary carcinoma
Post- sphincterotomy bleeding:

R
Reference level for enzyme in laboratory data: List the laboratory reference level for each
individual patient
Record ID: The unique ID that will be generated after the patient is randomized in RedCap. The
study subject after randomization will be referred with respect to this Record ID in all future
references.

Serum creatinine > 1.7: Current lab report must show this to be considered as an exclusion
criteria
Sphincter of Oddi Dysfunction: Rome III revision of the Milwaukee classification
Type I patients present with biliary-type pain, abnormal aminotransferases, bilirubin or alkaline
phosphatase (>2 times normal values) documented on two or more occasions, and a dilated bile
duct (>8 mm on ultrasound).
Type II patients present with biliary-type pain and one of the previously mentioned laboratory or
imaging abnormalities.
Type III patients complain only of recurrent biliary-type pain and have none of the previously
mentioned laboratory or imaging criteria.
Delayed drainage of contrast from the common bile duct after more than 45 minutes in the
supine position, Sphincter of Oddi Manometry proved SOD will be considered as one of the
major inclusion criteria if available.
Sphincter: A ring-shaped muscle that surrounds a body opening and that can tighten to close the
opening. (Merriam Webster`s Dictionary)
Sphincterotomy: Surgical incision of a sphincter. Sphincterotomy
ASGE definition of sphincterotomy for patient information:
Sphincterotomy is cutting the muscle that surrounds the opening of the ducts, or the papilla. This
cut is made to enlarge the opening. The cut is made while your doctor looks through the ERCP
scope at the papilla, or duct opening. A small wire on a specialized catheter uses electric current
to cut the tissue. A sphincterotomy does not cause discomfort, you do not have nerve endings
there. The actual cut is quite small, usually less than a 1/2 inch. This small cut, or
sphincterotomy, allows various treatments in the ducts. Most commonly the cut is directed
towards the bile duct, called a biliary sphincterotomy. Occasionally, the cutting is directed
towards the pancreatic duct, depending on the type of treatment you need.
Standard clinical contraindications to ERCP: Any contraindication due to which ERCP will
not be done. You will not likely come across this situation as patient is usually screened prior to
scheduling for ERCP but due to varies institutional policies, this has been included.
Stent Placement: ASGE definition of stent placement for patient information:
Stents are placed into the bile or pancreatic ducts to bypass strictures, or narrowed parts of the
duct. These narrowed areas of the bile or pancreatic duct are due to scar tissue or tumors that
cause blockage of normal duct drainage. There are two types of stents that are commonly used.
The first is made of plastic and looks like a small straw. A plastic stent can be pushed through
the ERCP scope into a blocked duct to allow normal drainage. The second type of stent is made
of metal wires that looks like the cross wires of a fence. The metal stent is flexible and springs
open to a larger diameter than plastic stents. Both plastic and metal stents tend to clog up after

several months and you may require another ERCP to place a new stent. Metal stents are
permanent while plastic stents are easily removed at a repeat procedure. Your doctor will choose
the best type of stent for your problem.
Stone Removal: ASGE definition:
The most common treatment through an ERCP scope is removal of bile duct stones. These stones
may have formed in the gallbladder and traveled into the bile duct or may form in the duct itself
years after your gallbladder has been removed. After a sphincterotomy is performed to enlarge
the opening of the bile duct, stones can be pulled from the duct into the bowel. A variety of
balloons and baskets attached to specialized catheters can be passed through the ERCP scope
into the ducts allowing stone removal. Very large stones may require crushing in the duct with a
specialized basket so the fragments can be pulled out through the sphincterotomy.

T
ERCP Time/ time of ERCP: Total time from the insertion of scope to withdrawal pf scope
Time of procedure: The time when the ERCP procedure was started on the subject. Eg, If the
ERCP starts at 3pm, the time of procedure will be 15:00.
Note: Time of ERCP is different from Time of procedure
Trainee involvement: List Yes/ No if Trainee is involved in actual ERCP procedure (such as
cannulation, sphincterotomy, stenting etc.) and not just insertion or withdrawal of scope
Type of Bile duct stent: All details of stent type like material, diameter, length, flanges, ends.
Ex: plastic, 7 Fr, 5 cm, single pig tail / straight, with / without flap

U
V
W
X
Y
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