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INDIEH Trial
Page 1 of 18
Form 1 Contact Basic Info

Record ID
__________________________________
Date subject signed consent
__________________________________
Time of Procedure
__________________________________
(Write time at which procedure is expected to
start)
Family Name
__________________________________
Given Name
__________________________________
Gender
Male
Female
Primary indication for ERCP
__________________________________
(Write brief primary indication of ERCP)
Inpatient / Outpatient Status at the time of consent
Inpatient
Outpatient
(This status is at the time of consenting for
ERCP)
Pre-procedure abdominal pain (on scale of 10)
0
1
2
3
4
5
6
7
8
9
10
(Write pain scale based on patient's perception)
Location of pain
1
2
3
4
5
6
7
8
9
(Choose all regions where the patient complains of
pain)
Initials of the Endoscopist (s)
__________________________________
(Write initials of the all the endoscopists
expected to be involved in ERCP in the format AK,
MK, VS)
Initials of site coordinator
__________________________________
(Write only initials of the coordinator involved
for this patient)
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Patient Contact Information

Complete Address
__________________________________
(Including Street, City, State, ZIP)
Primary Phone Number
__________________________________
Secondary Phone Number
__________________________________
E-mail
__________________________________
Patient Consent Form

Upload Consent Form
If not randomized, reason for exclusion
(Upload the First and Last pages of consent form

showing the patient name and the signatures
respectively)
__________________________________
(Please explain reason for consenting but not
randomizing the patient)
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Form 2 Screening Questions

Was the patient consented for INDIEH trial?
Consented
Was not consented
(Please make sure patient is consented, before you
randomize)
Major Inclusion Criteria - at least one item must be answered YES to be aligible
History of post-ERCP pancreatitis (PEP)
Yes
No
(Documented history of PEP in medical records, at
least 1 episode)
Pancreatic sphincterotomy
Yes
No
(New sphincterotomy or extension of existing
sphincterotomy. Confirm with endoscopist /
technician)
Type of pancreatic sphincterotomy

Pre-cut (access) sphincterotomy
Type of Pre-Cut (access) sphincterotomy
needle-knife
traction/pull type
Yes
No
(Confirm with endoscopist / technician)
Freehand
Septotomy
> 5 cannulation attempts/ 10 minutes to cannulate
Yes
No
(Each attempt as defined by endoscopist, time also
as decided by endoscopist)
Failed cannulation
Yes
No
(Inability to cannulate even after multiple
attempts, as defined by endoscopist)
Pneumatic dilation of an intact sphincter
Yes
No
(Does not qualify if sphincterotomy was performed.
Confirm with endoscopist / technician)
Sphincter of Oddi dysfunction of Type I or Type II
Yes
No
(Type 1 SOD: patients 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 SOD: patients with
biliary-type pain and one of the previously
mentioned laboratory or imaging abnormalities. )
SOD Type
SOD Type I
SOD Type II
(Describe type of SOD from definition above)
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Minor Inclusion Criteria - at least two items must be answered YES to be eligible OR Yes above
in Major Inclusion Criteria
Age < 50 & Female gender
Yes
No
(Must be both female and age < 50)
History of acute pancreatitis (at least 2 episodes)
Yes
No
(Must have at least 2 documented episodes of acute
pancreatitis)
>2 pancreatic injections, with at least 1 injection

in tail
Yes
No
Pancreatic acinarization
Yes
No
Pancreatic Brush Cytology
Yes
No
Exclusion Criteria - All items must be answered NO

Unwillingness or inability to consent for study
Yes
No
(Please make sure that he patient can be followed
up for at least 2 days)
Age < 18 years
Yes
No
Intrauterine Pregnancy
Yes
No
Breast feeding mother
Yes
No
Standard clinical contraindications to ERCP
Yes
No
Sphincter of Oddi dysfunction of Type III
Yes
No
(SOD Type III: patients complain only of recurrent
biliary-type pain and have none of the previously
mentioned laboratory or imaging criteria)
Pancreatic duct stent placed for any reason
Yes
No
(If pancreatic duct stent is placed for any
reason, do not include the patient)
Ampullectomy
Yes
No
(Please confirm with endoscopist / technician)
Allergy/hypersensitivity/contrindications to NSAIDs
Yes
No
Allergy/hypersensitivity/contrindications to
Epinephrine
Yes
No
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Received NSAIDs in prior 48 hours (except Aspirin 325

mg/day or less)
Serum creatinine > 1.7
Active or recent gastrointestinal hemorrhage (within

7 days before ERCP)
Yes
No
Yes
No
(Chronic renal disease patients)
Yes
No
Acute pancreatitis (lipase peak) within 72 hours

prior to ERCP
Yes
No
(Acute pancreatitis as defined by lipase elevation
only will be considered)
Chronic calcific pancreatitis
Yes
No
(Calcifications must be present and confirmed
based on imaging evidence)
Pancreatic head mass involving main pancreatic duct
Yes
No
(Ductal involvement must be present, possible
leading to obstruction and atrophic changes)
ERCP for biliary or pancreatic stent removal without

anticipated procedure based inclusion criteria
Yes
No
(Should be just stent removal and no procedure
based inclusion criteria such as sphincterotomy,
difficult cannulation)
Prior biliary sphincterotomy, now scheduled for

biliary therapy without procedure based inclusion
criteria
Yes
No
(Extension of prior sphincterotomy will be
considered new sphincterotomy)
Procedure performed on major papilla/ventral

pancreatic duct in patient with pancreas divisum
(dorsal duct not attempted or injected)
Anticipated inability to follow protocol
Yes
No
Yes
No
(Do not randomize patient if they cannot be
followed up for at least 24 hours after ERCP)
FINAL INCLUSION DECISION

Does the patient meet criteria for high risk?
Yes
No
(Randomize patient only when the answer is yes)
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Randomization Protocol
Randomization Date:
Was an emergency envelope used to randomize the
patient (if REDCap was unavailable during the
procedure).
Emergency Envelope #
__________________________________
Yes
No
__________________________________
Arm / Drug group to which the patient has been

randomized to
Arm A
Arm B
Arm C
Arm D
Arm E
Arm F
Arm G
Arm H
Arm / Drug group to which the patient has been

randomized to
Arm
Arm
Arm
Arm
Arm
Arm
Arm
Arm
A
B
C
D
E
F
G
H
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Form 3 Detailed Patient And Procedural Data
INDIEH Trial
Page 7 of 18
Patient related information

Date of birth
__________________________________
(Month-Date-Year)
Age in years
__________________________________
(No need to fill on paper, will be calculated
based on DOB)
Race
American Indian/Alaska Native

Asian
Native Hawaiian or Other Pacific Islander
Black or African American
White
More Than One Race
Unknown / Not Reported
Weight
__________________________________
(In kilograms)
Height
__________________________________
(In centimeter (cm))
BMI
__________________________________
Past Medical / Surgical History

SOD details
SOD Type I
SOD Type II
SOD Type III
SOD clinically suspected
SOD manometry documented
No SOD
(Choose all applicable. Please see definitions
document)
Clinical suspicion of Irritable Bowel Syndrome (IBS)
Yes
No
(Based on Rome III criteria, please see
definitions document and ask questions
applicable)
Taking daily cardioprotective aspirin
Yes
No
Dosage of daily cardioprotective aspirin
81 mg
325 mg
Not applicable
Gall stones
None
Cholelithiasis
Choledocholithiasis
(Gall stones diagnosed and confirmed based on
imaging, as described in medical records)
Prior cholecystectomy
Yes
No
(Based on medical records)
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Intravenous Fluids
Was intravenous fluids given prior to ERCP
Volume of intravenous fluid given 24 hours before ERCP
Was intravenous fluids given after ERCP
Yes
No
__________________________________
(Total volume in the day before ERCP. Write in ml)
Yes
No
Volume of fluids given during ERCP and in observation

period (upto 3-6 hrs after ERCP)
__________________________________
(Write in ml. Include fluid given during ERCP and
in observation period immediately after ERCP.
Fluid given beyond observation period will be
recorded on Day 2 follow-up)
Type of intravenous fluids given during ERCP
__________________________________
(Please write all types as - NS, LR, D5 etc)
Procedure related information as described by the endoscopist

Details of indication (s) for ERCP
(Describe all indications each separated by a comma.)
ERCP time (min)
__________________________________
(Total duration from 'scope in' to 'scope out')
Type of anesthesia used
__________________________________
(Write the name of anaethesia agent used. For
example: propofol)
Type of electrocautery current used
Pure cut
Blended / Mixed
Sequential: pure cut and then blended
Not applicable
Pancreas divisum
Yes
No
Juxtapapillary diverticula
Yes
No
Duration for cannulation (min)
__________________________________
(Cannulation time as defined by endoscopist)
Number of cannulation attempts
1
2
3
4
5
6
>6
(Any event touching the papilla is considered as
an attempt as defined by endoscopist)
Cannulation technique used
Guidewire-assisted
Contrast-assisted
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Number of guide wire passes to pancreatic duct
0
1
2
3
4
5
6
>6
(In guide wire assisted cannulation)
Number of pancreatic injections
0
1
2
3
4
5
6
>6
Sphincter of Oddi manometry performed
Yes
No
Minor papilla cannulation
Yes
No
Minor papilla sphincterotomy
No
Yes
Yes: Pre cut sphincterotomy
(Choose one option as applicable)
Biliary sphincterotomy
Yes
No
(New sphincterotomy or extension of existing
sphincterotomy)
Biliary stent placement
Yes
No
(New stent placement or exchange of biliary stent)
Type of Bile duct stent
__________________________________
(Write all details including length, diameter,
flaps, ends, material, number. For example
plastic, 7 Fr, 5 cm, straight, with flap)
Common bile duct diameter
__________________________________
(in millimeter (mm) as noted on ERCP or CT)
Pancreaticobiliary malignancy
Yes
No
(List any known pancreatico biliary malignancy.
See definitions for examples)
Tainee involved
Yes
No
(Say 'Yes' only if trainee is involved in actual
ERCP involving cannulation, sphincterotomy, stent
placement etc)
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Supplementary For Genetic Study
PRE - ERCP
Family history
If 'Yes' for any of the family history categories.

Please list details for each positive family history
a) relationship with the family member, b) age at
diagnosis c) if the relative is smoker d) if the
relative is alcoholic e) etiology (if known)
Acute pancreatitis
Chronic pancreatitis
Pancreatic cancer
__________________________________
(Please fill details for each positive family history (one for
Acute pancreatitis history

Have you ever had acute pancreatitis?
Yes
No
Have you ever been hospitalized (atleast overnight)

for acute pancreatitis?
Yes
No
What was your age when you were first hospitalized

for acute pancreatitis attack?
__________________________________
What was the duration for your first hospitalization

for pancreatitis?
__________________________________
Have you had more than one attack of acute

pancreatitis?
How long does an attack of acute pancreatitis last?
Yes
No
__________________________________
Chronic pancreatitis history

Have you been diagnosed with chronic pancreatitis?
Yes
No
At what age did you first start having symptoms of

chronic pancreatitis?
__________________________________
At what age were you first diagnosed with chronic

pancreatitis?
__________________________________
Have you ever been diagnosed with glucose intolerance

or diabetes?
Gluco intolerance
Type 1 Diabetes
Type 2 Diabetes
Pancreatitis related Diabetes
Have you ever smoked cigarettes?
Yes
No (less than 100 in lifetime)
What age did you start smoking?

Do you still smoke?
At what age did you quit smoking?
__________________________________
Yes
No
__________________________________
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On average how many cigarettes do / did you smoke?
__________________________________
Assessment of second hand or environmental exposure

to smoking - a) as a child or later, did you live
with a family member who smoked inside house Yes/
No. If yes, how long did you live with the family
member. b) do you work in an environment with a
colleague smoking in a confined environment Yes /
No. If yes, for how many years were you working in
such environment.
__________________________________
Was there ever a time when you drank beer, wine, wine
coolers, liquor, or mixed drinks?
Do you currently drink alcohol?
Yes
No (less than 20 drinks in lifetime)
(one shot of liquor, a mixed drink, one glass of
wine or one beer is considered one drink)
Yes
No
How old were you when you first started drinking

alcohol?
__________________________________
How old were you when you began drinking the most
alcohol in your life?
__________________________________
What was the largest number of drinks you drank in a

single day?
__________________________________
(one shot of liquor, a mixed drink, one glass of
wine or one beer is considered one drink)
On the AVERAGE about how many drinks would you have

on a drinking day?
__________________________________
What is the maximum number of days each month you

drink alcohol?
__________________________________
How many drinks did it take to make you feel high?
__________________________________
How many drinks were you able to hold in a day?
__________________________________
Did close friends or relatives worry or complain

about your drinking?
Yes
No
Did you sometimes take a drink in the morning when

you first got up?
Yes
No
Did a friend or family member ever tell you about

things you said or did while you were drinking that
you could not remember?
Yes
No
Did you feel the need to cut down on your drinking?
Yes
No
Morphological features of the pancreas - Please

include EUS features, ERCP / MRCP Cambridge
classification, CT features including details of the
calcifications.
__________________________________
(Please copy from the reports)
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INDIEH Trial
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Form 4 Followup Day 2

Abdominal pain
Yes
No
(New or existing abdominal pain)
If abdominal pain is present, quantify abdominal pain

(on scale of 10)
0
1
2
3
4
5
6
7
8
9
10
(Pain as described by the patient)
Location of abdominal pain
1
2
3
4
5
6
7
8
9
(List all locations from figure)
List of medications and dose, taken by the patient

from the end of ERCP to 24 hours after ERCP
__________________________________
(List all medications within 24 hours after ERCP. The ides i
Hospitalization (or prolongation of existing

hospitalization) after ERCP
Yes
No
(Say Yes if patient is in hospital after ERCP)
Duration of hospitalization
__________________________________
(in days, from the day of ERCP)
ICU requirement
No
Yes: due to post-ERCP pancreatitis
Yes: due to reason other than post-ERCP
pancreatitis
(Patient admitted to ICU after ERCP)
Acute pancreatic fluid collection or acute necrotic

collection due to post-ERCP pancreatitis
None
Acute pancreatic fluid collection
Acute necrotic collection
(These have to be caused / found after post ERCP
pancreatitis)
Intervention (surgical, radiologic, or endoscopic) to

manage complications of ERCP
If yes for question above, describe the intervention
and indication
CT scan of abdomen performed within 14 days of ERCP
If yes for the question above, findings in CT
Mortality due to post-ERCP pancreatitis
Yes
No
__________________________________
Yes
No
__________________________________
Yes
No
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Mortality from other reason - Give reason for

mortality and day after ERCP
__________________________________
(Briefly explain primary cause of death and how
many days after the ERCP)
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Abdominal pain
Yes
No
(New or existing abdominal pain between day 2-day5
after ERCP)

(on scale of 10)
0
1
2
3
4
5
6
7
8
9
10
(Pain as described by the patient)
1
2
3
4
5
6
7
8
9

hospitalization) for at least 2 days - night of ERCP
& next night
Yes
No
__________________________________
ICU requirement
No
pancreatitis

None
pancreatitis)

and indication
Yes
No
__________________________________
Yes
No
__________________________________
Yes
No
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__________________________________
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Abdominal pain

(on scale of 10)

hospitalization) for at least 2 days - night of ERCP
& next night
Yes
No
(New or existing abdominal pain between day 5 to
day 30 after ERCP)
0
1
2
3
4
5
6
7
8
9
10
1
2
3
4
5
6
7
8
9
Yes
No
__________________________________
ICU requirement
No
pancreatitis

None
pancreatitis)

and indication
Yes
No
__________________________________
Yes
No
__________________________________
Yes
No
__________________________________
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Form 5 Laboratory Data

Amylase or lipase > 3x ULN after 24 hours
Yes
No
(Should be checked close to 24 hours after ERCP,
likely Day 2)
Amylase level on the day after ERCP
__________________________________
(Close to 24 hours after ERCP)
Date and Time at which blood was collected,

approximately
__________________________________
Amylase normal upper reference level
__________________________________
(Check from the lab report, write only upper limit
of normal)
Lipase level on the day after ERCP
__________________________________
(Close to 24 hours after ERCP)

approximately
__________________________________
Lipase normal reference level
__________________________________
(Check from the lab report. Write only the upper
limit of normal)
Any other relevant laboratory data on the day after

ERCP
__________________________________
(Include bilirubin levels, WBC)
Amylase level 2 days after ERCP
__________________________________
(If available)

approximately
__________________________________
Amylase normal upper reference level
__________________________________
(Check from the lab report, write only upper limit
of normal)
Lipase level 2 days after ERCP
__________________________________
(If available)

approximately
__________________________________
Lipase normal reference level
__________________________________
(Check from the lab report. Write only the upper
limit of normal)
Amylase and Lipase levels taken beyond day 2, if

'late onset pancreatitis' was suspected or occured.
__________________________________
(Write amylase and lipase levels, dates when checked, up
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Form 6 Adverse Events

Evidence of hypertension after ERCP (upto 3-6 hours)
Yes
No
(This is only for day of ERCP)
Evidence of arrythmias after ERCP (upto 3-6 hours)
Yes
No
Evidence of over bleeding (upto 3-6 hours after ERCP)
Yes
No
Details of complications listed above, if present.

Give the type of bleeding
(hematemesis,melena,hematochezia or bright red blood
per rectum). If hospitalization, transfusion,
angiography or surgery was required to manage
bleeding.
__________________________________
Post-sphincterotomy bleeding
Yes
No
Perforation from ERCP
Yes
No
Myocardial infarction
Yes
No
Cerebrovascular accident
Yes
No
Acute renal failure
Yes
No
(Should be new onset renal failure)
Pancreatic necrosis/Acute necrotic collection
Yes
No
Pancreatic pseudocyst/Acute pancreatic fluid

collection
Yes
No
Details of the adverse events listed above, including

date of onset and date of resolution
Reportable adverse events
Give details of the reportable adverse events such as

day of event onset, cause of death, other details
related to the event to be used by DSMB to evaluate
for the events relation with INDIEH Trial related
intterventions
__________________________________
Hospitalization or intervention required to manage
bleeding
severe post-ERCP pancreatitis
organ failure resulting from pancreatitis
perforation
allergic reaction
death
arrythmia or hypertension within 6 hours after ERCP
(Mail a pdf copy of this form to clinical trial
monitor if any of these is marked yes)
__________________________________
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Confidential

Form 1 Contact Basic Info

Date subject signed consent

Primary indication for ERCP

Inpatient / Outpatient Status at the time of consent

Pre-procedure abdominal pain (on scale of 10)

Initials of the Endoscopist (s)

Initials of site coordinator

Patient Contact Information

Primary Phone Number

Secondary Phone Number

Patient Consent Form

If not randomized, reason for exclusion

(Upload the First and Last pages of consent form

Form 2 Screening Questions

Type of pancreatic sphincterotomy

Type of Pre-Cut (access) sphincterotomy

> 5 cannulation attempts/ 10 minutes to cannulate

Pneumatic dilation of an intact sphincter

Sphincter of Oddi dysfunction of Type I or Type II

History of acute pancreatitis (at least 2 episodes)

>2 pancreatic injections, with at least 1 injection

Pancreatic Brush Cytology

Exclusion Criteria - All items must be answered NO

Age < 18 years

Breast feeding mother

Standard clinical contraindications to ERCP

Sphincter of Oddi dysfunction of Type III

Pancreatic duct stent placed for any reason

Received NSAIDs in prior 48 hours (except Aspirin 325

Active or recent gastrointestinal hemorrhage (within

Acute pancreatitis (lipase peak) within 72 hours

Chronic calcific pancreatitis

Pancreatic head mass involving main pancreatic duct

ERCP for biliary or pancreatic stent removal without

Prior biliary sphincterotomy, now scheduled for

Procedure performed on major papilla/ventral

FINAL INCLUSION DECISION

Arm / Drug group to which the patient has been

Arm / Drug group to which the patient has been

Form 3 Detailed Patient And Procedural Data

Patient related information

American Indian/Alaska Native

Past Medical / Surgical History

Clinical suspicion of Irritable Bowel Syndrome (IBS)

Taking daily cardioprotective aspirin

Dosage of daily cardioprotective aspirin

Volume of fluids given during ERCP and in observation

Type of intravenous fluids given during ERCP

Procedure related information as described by the endoscopist

(Describe all indications each separated by a comma.)

ERCP time (min)

Type of anesthesia used

Type of electrocautery current used

Duration for cannulation (min)

Number of cannulation attempts

Cannulation technique used

Number of guide wire passes to pancreatic duct

Number of pancreatic injections

Sphincter of Oddi manometry performed

Minor papilla cannulation

Minor papilla sphincterotomy

Biliary stent placement