ID

45872

Descripción

Prebot Pilot Sphincter of Oddi botulinum toxin injection to prevent pancreatic fistula after distal pancreatectomy.

Palabras clave

Versiones (1)
  1. 26/10/23 26/10/23 - Nelly Zental
Titular de derechos de autor

Hackert T, Klaiber U, Hinz U, Kehayova T, Probst P, Knebel P, Diener MK, Schneider L, Strobel O, Michalski CW, Ulrich A, Sauer P, Büchler MW

Subido en

26 de octubre de 2023

DOI

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Licencia

Creative Commons BY 4.0
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PREBOT trial

Inglés

Visit 1: Enrollment and Randomization

13 formularios  
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Screening
Descripción

Screening

Alias
UMLS CUI [1,1]
C0220908
Screening No. (*must provide value)
Descripción

Screening No.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0600091
Date of screening
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
Demographic data
Descripción

Demographic data

Alias
UMLS CUI [1,1]
C1704791
Gender
Descripción

Gender

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0079399
Age
Descripción

Age

Tipo de datos

integer

Unidades de medida
  • yeas
Alias
UMLS CUI [1,1]
C0001779
yeas
Height
Descripción

Height

Tipo de datos

integer

Unidades de medida
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight
Descripción

Weight

Tipo de datos

integer

Unidades de medida
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Woman of childbearing potential
Descripción

childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
Result of pregnancy test
Descripción

pregnancy test

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Inclusion criteria
Descripción

Inclusion criteria

Alias
UMLS CUI [1,1]
C1512693
Patient scheduled for elective, primary DP (open or minimally invasive technique)
Descripción

elective primary DP

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0439608
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C5706958
UMLS CUI [1,4]
C5706957
Male or female patient >= 18 years of age
Descripción

of full age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0682058
Ability of patient to understand character and individual consequences of the clinical trial
Descripción

Ability to understand character & consequences

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1273101
Written informed consent (must be available before enrollment in the trial)
Descripción

Written informed consent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0742766
UMLS CUI [1,2]
C4082015
Date of informed consent
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention.
Descripción

negative pregnancy test and adequate contraception

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4324275
UMLS CUI [1,2]
C0427780
UMLS CUI [1,3]
C4071839
UMLS CUI [1,4]
C1171186
UMLS CUI [1,5]
C0814861
Exclusion criteria
Descripción

Exclusion criteria

Alias
UMLS CUI [1,1]
C0680251
Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
Descripción

Serious cardiovascular disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205404
UMLS CUI [1,2]
C0007222
Renal insufficency, i.e. creatinine clearance <30 mL/min (estimated by Cockroft-Gault)
Descripción

Renal insufficency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
Liver cirrhosis of any Child-Pugh grade
Descripción

Liver cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
American Society of Anesthesiologists (ASA) score > III
Descripción

ASA > III

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4061000
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
Descripción

Hypersensitivity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0006055
Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing botulinum toxin injection
Descripción

Neuromuscular disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027868
Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis.
Descripción

Condition making intervention impossible / obsolete

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4743675
UMLS CUI [1,2]
C0808232
UMLS CUI [1,3]
C0013301
History of BTX application and either positive test or missing test for neutralizing antibodies to botulinum toxin.
Descripción

Positive or missing antibody test to BTX

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0700702
UMLS CUI [1,3]
C1142254
UMLS CUI [1,4]
C1705492
UMLS CUI [1,5]
C1609515
Understanding or language problems
Descripción

Understanding or language problems

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1145677
UMLS CUI [1,2]
C1405458
UMLS CUI [1,3]
0162340
Inability to comply with study and/or follow-up procedures
Descripción

Inability to comply

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0457432
UMLS CUI [1,2]
C1522577
UMLS CUI [1,3]
C0184661
Pregnany or lactation
Descripción

Pregnany or lactation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Concurrent participation in another interventional clinical trial
Descripción

Concurrent participation

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0008976
Any condition or situation which could result in an undue risk for the patient and/or influence outcome measures in the opinion of the investigator.
Descripción

Undue risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205350
UMLS CUI [1,3]
C0035647
UMLS CUI [1,4]
C4054723
UMLS CUI [1,5]
C0086749
Baseline clinical data
Descripción

Baseline clinical data

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1516606
Previous abdominal surgery
Descripción

Previous abdominal surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0198482
If yes, please specify
Descripción

If yes, please specify

Alias
UMLS CUI [1,1]
C1521902
appendectomy
Descripción

appendectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0003611
cholecystectomy
Descripción

cholecystectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008320
hernia repair (abdominal wall)
Descripción

hernia repair (abdominal wall)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C5441433
colorectal resection
Descripción

colorectal resection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0555952
UMLS CUI [1,2]
C0728940
rectal resection
Descripción

rectal resection

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0193062
small bowel surgery
Descripción

small bowel surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0192571
gastric surgery
Descripción

gastric surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0192398
hepatic surgery
Descripción

hepatic surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0193373
pancreatic surgery
Descripción

pancreatic surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2033062
splenectomy
Descripción

splenectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0037995
renal surgery
Descripción

renal surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0194053
hysterectomy
Descripción

hysterectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020699
ovariectomy
Descripción

ovariectomy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0029936
C-section
Descripción

C-section

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007876
prostate surgery
Descripción

prostate surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0194790
bladder surgery
Descripción

bladder surgery

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0194361
other
Descripción

other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205394
If other, please specify
Descripción

Specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1521902
If yes: Year of last surgery
Descripción

Year

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C0011008
If yes: Type of last surgery
Descripción

Type

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1517741
UMLS CUI [1,2]
C1521902
Relevant prior / concomitant diseases
Descripción

Relevant prior / concomitant diseases

Alias
UMLS CUI [1,1]
C0150941
Cardiac
Descripción

Cardiac

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018799
If yes: Myocardial infarction
Descripción

Myocardial infarction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027051
If yes: Congestive heart failure
Descripción

Congestive heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0018802
Pulmonary
Descripción

Pulmonary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024115
If yes: Chronic obstructive pulmonary disease (COPD)
Descripción

COPD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0024117
If yes: Bronchial asthma
Descripción

Bronchial asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205039
Renal
Descripción

Renal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022658
If yes: Renal insufficiency
Descripción

Renal insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
Hepatic
Descripción

Hepatic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023895
If yes: Liver cirrhosis
Descripción

Liver cirrhosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
Neuromuscular disorder
Descripción

Neuromuscular disorder

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027868
If yes, please specify
Descripción

Specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1521902
Smoking and Alcohol
Descripción

Smoking and Alcohol

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0037369
Smoking
Descripción

Smoking

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1519386
If former / current smoker: Cigarettes per day
Descripción

Cigarettes per day

Tipo de datos

float

Alias
UMLS CUI [1,1]
C3694146
If former / current smoker: Years of consumption
Descripción

Years of consumption

Tipo de datos

float

Alias
UMLS CUI [1,1]
C1303175
Alcohol abuse
Descripción

Alcohol abuse

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0085762
If former / persistent alcohol abuse: Years of abuse
Descripción

Years of abuse

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3700016
ASA Score
Descripción

ASA Score

Alias
UMLS CUI [1,1]
C1531480
ASA
Descripción

ASA

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1531480
Previous radio-/ chemotherapy (within the last 6 months)
Descripción

Previous radio-/ chemotherapy (within the last 6 months)

Alias
UMLS CUI [1,1]
C1384668
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0392920
Previous radiotherapy (within the last 6 months)
Descripción

Previous radiotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0436307
UMLS CUI [1,3]
C4082120
UMLS CUI [1,4]
C0205156
If yes, please specify region (tissue/organ)
Descripción

specify region

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0005898
UMLS CUI [1,3]
C0040300
UMLS CUI [1,4]
C0178784
If yes: End of radiotherapy (month)
Descripción

Month radiotherapy end

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0439231
If yes: End of radiotherapy (year)
Descripción

Year radiotherapy end

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0439234
Previous chemotherapy (within the last 6 months)
Descripción

Previous chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C4082120
UMLS CUI [1,3]
C0205156
If yes, please specify chemotherapy regime
Descripción

Chemotherapy regime

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0392920
If other regime, please specify
Descripción

Specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
Number of Cycles FOLFIRINOX (total)
Descripción

Number of Cycles FOLFIRINOX

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2045831
UMLS CUI [1,2]
C0879464
Number of Cycles Gemcitabine (total)
Descripción

Number of Cycles Gemcitabine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2045831
UMLS CUI [1,2]
C0045093
Number of Cycles (total)
Descripción

Number of Cycles other

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2045831
If yes: End of chemotherapy (month)
Descripción

Month chemotherapy end

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0439231
If yes: End of chemotherapy (year)
Descripción

Year chemotherapy end

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0439234
Previous botulinum toxin treatment
Descripción

Previous botulinum toxin treatment

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1321035
Previous botulinum toxin application
Descripción

Previous BTX application

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C1321035
If yes: Indication
Descripción

Indication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3146298
If yes: Result of test for neutralizing antibodies
Descripción

Testresult Antibodies

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1142254
UMLS CUI [1,2]
C1274040
Pancreas-specific medical history
Descripción

Pancreas-specific medical history

Alias
UMLS CUI [1,1]
C0030274
UMLS CUI [1,2]
C0262926
Indication for planned surgery
Descripción

Indication

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0543467
If other indication, please specify
Descripción

Specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1521902
Preexisting diabetes mellitus
Descripción

Diabetes mellitus

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0011849
If yes: Insulin dependent
Descripción

Insulin dependent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
Preexisting exocrine insufficiency
Descripción

Preexisting exocrine insufficiency

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2347662
UMLS CUI [1,2]
C0267963
Prior / Concomitant Medication
Descripción

Prior / Concomitant Medication

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2826666
Any Concomitant Medication intake?
Descripción

Concomitant Medication intake

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2826666
If yes, please fill out eForm 'Concomitant Medication'
Descripción

If yes, please fill out eForm 'Concomitant Medication'

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C3273494
Questionnaires
Descripción

Questionnaires

Alias
UMLS CUI [1,1]
C0034394
EORTC QLQ-C30 completed
Descripción

EORTC QLQ-C30

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4055104
UMLS CUI [1,2]
C1556116
EORTC QLQ-PAN26 completed
Descripción

EORTC QLQ-PAN26

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C4288326
UMLS CUI [1,2]
C1556116
Randomization
Descripción

Randomization

Alias
UMLS CUI [1,1]
C0034656
Date of Randomization
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
Randomization number
Descripción

Number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0034656
Randomization group
Descripción

Group

Tipo de datos

float

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0441833
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Similar models

Visit 1: Enrollment and Randomization

13 formularios
  1. StudyEvent: PREBOT Pilot
    1. Visit 1: Enrollment and Randomization
    2. Visit 2: Endoscopic intervention
    3. Visit 3: Operation
    4. Visit 4: POD 3
    5. Visit 5: Day of discharge
    6. Visit 6: POD 30
    7. Visit 7: 3 months post OP/ premature discontinuation
    8. Signature
  2. StudyEvent: Complications
    1. Complications
  3. StudyEvent: Readmission To Hospital (repeatable instrument)
    1. Readmission To Hospital (repeatable instrument)
  4. StudyEvent: Adverse Events (repeatable instrument)
    1. Adverse Events (repeatable instrument)
  5. StudyEvent: Concomitant Medication
    1. Concomitant Medication
  6. StudyEvent: Protocol Violation (repeatable instrument)
    1. Protocol Violation (repeatable instrument)
  7. StudyEvent: Patient report: EORTC QLQ-C30
  8. StudyEvent: Patient report: EORTC QLQ-PAN26
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Screening
C0220908 (UMLS CUI [1,1])
Screening No.
Item
Screening No. (*must provide value)
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date
Item
Date of screening
date
C0011008 (UMLS CUI [1,1])
Item Group
Demographic data
C1704791 (UMLS CUI [1,1])
Item
Gender
integer
C0079399 (UMLS CUI [1,1])
CL.1
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Age
Item
Age
integer
C0001779 (UMLS CUI [1,1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1,1])
Weight
Item
Weight
integer
C0005910 (UMLS CUI [1,1])
childbearing potential
Item
Woman of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
Item
Result of pregnancy test
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL.40
Code List
Result of pregnancy test
CL Item
negative (1)
CL Item
positive (2)
Item Group
Inclusion criteria
C1512693 (UMLS CUI [1,1])
elective primary DP
Item
Patient scheduled for elective, primary DP (open or minimally invasive technique)
boolean
C0439608 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C5706958 (UMLS CUI [1,3])
C5706957 (UMLS CUI [1,4])
of full age
Item
Male or female patient >= 18 years of age
boolean
C0001779 (UMLS CUI [1,1])
C0682058 (UMLS CUI [1,2])
Ability to understand character & consequences
Item
Ability of patient to understand character and individual consequences of the clinical trial
boolean
C0021430 (UMLS CUI [1,1])
C1273101 (UMLS CUI [1,2])
Written informed consent
Item
Written informed consent (must be available before enrollment in the trial)
boolean
C0742766 (UMLS CUI [1,1])
C4082015 (UMLS CUI [1,2])
Date
Item
Date of informed consent
date
C0011008 (UMLS CUI [1,1])
negative pregnancy test and adequate contraception
Item
For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention.
date
C4324275 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C4071839 (UMLS CUI [1,3])
C1171186 (UMLS CUI [1,4])
C0814861 (UMLS CUI [1,5])
Item Group
Exclusion criteria
C0680251 (UMLS CUI [1,1])
Serious cardiovascular disease
Item
Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
boolean
C0205404 (UMLS CUI [1,1])
C0007222 (UMLS CUI [1,2])
Renal insufficency
Item
Renal insufficency, i.e. creatinine clearance <30 mL/min (estimated by Cockroft-Gault)
boolean
C1565489 (UMLS CUI [1,1])
Liver cirrhosis
Item
Liver cirrhosis of any Child-Pugh grade
boolean
C0023890 (UMLS CUI [1,1])
ASA > III
Item
American Society of Anesthesiologists (ASA) score > III
boolean
C4061000 (UMLS CUI [1,1])
Hypersensitivity
Item
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
boolean
C0020517 (UMLS CUI [1,1])
C0006055 (UMLS CUI [1,2])
Neuromuscular disorder
Item
Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing botulinum toxin injection
boolean
C0027868 (UMLS CUI [1,1])
Condition making intervention impossible / obsolete
Item
Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis.
boolean
C4743675 (UMLS CUI [1,1])
C0808232 (UMLS CUI [1,2])
C0013301 (UMLS CUI [1,3])
Positive or missing antibody test to BTX
Item
History of BTX application and either positive test or missing test for neutralizing antibodies to botulinum toxin.
boolean
C0262926 (UMLS CUI [1,1])
C0700702 (UMLS CUI [1,2])
C1142254 (UMLS CUI [1,3])
C1705492 (UMLS CUI [1,4])
C1609515 (UMLS CUI [1,5])
Understanding or language problems
Item
Understanding or language problems
boolean
C1145677 (UMLS CUI [1,1])
C1405458 (UMLS CUI [1,2])
0162340 (UMLS CUI [1,3])
Inability to comply
Item
Inability to comply with study and/or follow-up procedures
boolean
C0457432 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Pregnany or lactation
Item
Pregnany or lactation
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Concurrent participation
Item
Concurrent participation in another interventional clinical trial
boolean
C2348568 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
Undue risk
Item
Any condition or situation which could result in an undue risk for the patient and/or influence outcome measures in the opinion of the investigator.
boolean
C0348080 (UMLS CUI [1,1])
C0205350 (UMLS CUI [1,2])
C0035647 (UMLS CUI [1,3])
C4054723 (UMLS CUI [1,4])
C0086749 (UMLS CUI [1,5])
Item Group
Baseline clinical data
C1442488 (UMLS CUI [1,1])
C1516606 (UMLS CUI [1,2])
Previous abdominal surgery
Item
Previous abdominal surgery
boolean
C0262926 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
Item Group
If yes, please specify
C1521902 (UMLS CUI [1,1])
appendectomy
Item
appendectomy
boolean
C0003611 (UMLS CUI [1,1])
cholecystectomy
Item
cholecystectomy
boolean
C0008320 (UMLS CUI [1,1])
hernia repair (abdominal wall)
Item
hernia repair (abdominal wall)
boolean
C5441433 (UMLS CUI [1,1])
colorectal resection
Item
colorectal resection
boolean
C0555952 (UMLS CUI [1,1])
C0728940 (UMLS CUI [1,2])
rectal resection
Item
rectal resection
boolean
C0193062 (UMLS CUI [1,1])
small bowel surgery
Item
small bowel surgery
boolean
C0192571 (UMLS CUI [1,1])
gastric surgery
Item
gastric surgery
boolean
C0192398 (UMLS CUI [1,1])
hepatic surgery
Item
hepatic surgery
boolean
C0193373 (UMLS CUI [1,1])
pancreatic surgery
Item
pancreatic surgery
boolean
C2033062 (UMLS CUI [1,1])
splenectomy
Item
splenectomy
boolean
C0037995 (UMLS CUI [1,1])
renal surgery
Item
renal surgery
boolean
C0194053 (UMLS CUI [1,1])
hysterectomy
Item
hysterectomy
boolean
C0020699 (UMLS CUI [1,1])
ovariectomy
Item
ovariectomy
boolean
C0029936 (UMLS CUI [1,1])
C-section
Item
C-section
boolean
C0007876 (UMLS CUI [1,1])
prostate surgery
Item
prostate surgery
boolean
C0194790 (UMLS CUI [1,1])
bladder surgery
Item
bladder surgery
boolean
C0194361 (UMLS CUI [1,1])
other
Item
other
boolean
C0205394 (UMLS CUI [1,1])
Specify
Item
If other, please specify
text
C1521902 (UMLS CUI [1,1])
Year
Item
If yes: Year of last surgery
date
C1517741 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If yes: Type of last surgery
integer
C1517741 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
CL.2
Code List
If yes: Type of last surgery
CL Item
open (1)
C0348025 (UMLS CUI [1,1])
CL Item
minimally invasive (2)
C0282624 (UMLS CUI [1,1])
Item Group
Relevant prior / concomitant diseases
C0150941 (UMLS CUI [1,1])
Cardiac
Item
Cardiac
boolean
C0018799 (UMLS CUI [1,1])
Myocardial infarction
Item
If yes: Myocardial infarction
boolean
C0027051 (UMLS CUI [1,1])
Congestive heart failure
Item
If yes: Congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
Pulmonary
Item
Pulmonary
boolean
C0024115 (UMLS CUI [1,1])
COPD
Item
If yes: Chronic obstructive pulmonary disease (COPD)
boolean
C0024117 (UMLS CUI [1,1])
Bronchial asthma
Item
If yes: Bronchial asthma
boolean
C0004096 (UMLS CUI [1,1])
C0205039 (UMLS CUI [1,2])
Renal
Item
Renal
boolean
C0022658 (UMLS CUI [1,1])
Renal insufficiency
Item
If yes: Renal insufficiency
boolean
C1565489 (UMLS CUI [1,1])
Hepatic
Item
Hepatic
boolean
C0023895 (UMLS CUI [1,1])
Liver cirrhosis
Item
If yes: Liver cirrhosis
boolean
C0023890 (UMLS CUI [1,1])
Neuromuscular disorder
Item
Neuromuscular disorder
boolean
C0027868 (UMLS CUI [1,1])
Specify
Item
If yes, please specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Smoking and Alcohol
C0001948 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])
Item
Smoking
integer
C1519386 (UMLS CUI [1,1])
CL.3
Code List
Smoking
CL Item
no smoker (1)
C0337672 (UMLS CUI [1,1])
CL Item
former smoker (2)
C0337671 (UMLS CUI [1,1])
CL Item
current smoker (3)
C3241966 (UMLS CUI [1,1])
Cigarettes per day
Item
If former / current smoker: Cigarettes per day
float
C3694146 (UMLS CUI [1,1])
Years of consumption
Item
If former / current smoker: Years of consumption
float
C1303175 (UMLS CUI [1,1])
Item
Alcohol abuse
integer
C0085762 (UMLS CUI [1,1])
CL.4
Code List
Alcohol abuse
CL Item
no alcohol abuse (1)
C1298908 (UMLS CUI [1,1])
CL Item
former alcohol abuse (2)
C0205156 (UMLS CUI [1,1])
CL Item
persistent alcohol abuse (3)
C0205322 (UMLS CUI [1,1])
Years of abuse
Item
If former / persistent alcohol abuse: Years of abuse
integer
C3700016 (UMLS CUI [1,1])
Item Group
ASA Score
C1531480 (UMLS CUI [1,1])
Item
ASA
integer
C1531480 (UMLS CUI [1,1])
CL.5
Code List
ASA
CL Item
I (1)
C0205447 (UMLS CUI [1,1])
CL Item
II (2)
C0205448 (UMLS CUI [1,1])
CL Item
III (3)
C0205449 (UMLS CUI [1,1])
CL Item
IV (4)
C0205450 (UMLS CUI [1,1])
Item Group
Previous radio-/ chemotherapy (within the last 6 months)
C1384668 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
Previous radiotherapy
Item
Previous radiotherapy (within the last 6 months)
boolean
C1514463 (UMLS CUI [1,1])
C0436307 (UMLS CUI [1,2])
C4082120 (UMLS CUI [1,3])
C0205156 (UMLS CUI [1,4])
specify region
Item
If yes, please specify region (tissue/organ)
text
C1521902 (UMLS CUI [1,1])
C0005898 (UMLS CUI [1,2])
C0040300 (UMLS CUI [1,3])
C0178784 (UMLS CUI [1,4])
Item
If yes: End of radiotherapy (month)
text
C0806020 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
CL.35
Code List
If yes: End of radiotherapy (month)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
Year radiotherapy end
Item
If yes: End of radiotherapy (year)
integer
C0806020 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Previous chemotherapy
Item
Previous chemotherapy (within the last 6 months)
boolean
C1514457 (UMLS CUI [1,1])
C4082120 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Item
If yes, please specify chemotherapy regime
integer
C1521902 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
CL.6
Code List
If yes, please specify chemotherapy regime
CL Item
FOLFIRINOX (1)
C4742253 (UMLS CUI [1,1])
CL Item
Gemcitabine (2)
C0045093 (UMLS CUI [1,1])
CL Item
other (3)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other regime, please specify
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Number of Cycles FOLFIRINOX
Item
Number of Cycles FOLFIRINOX (total)
integer
C2045831 (UMLS CUI [1,1])
C0879464 (UMLS CUI [1,2])
Number of Cycles Gemcitabine
Item
Number of Cycles Gemcitabine (total)
integer
C2045831 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
Number of Cycles other
Item
Number of Cycles (total)
integer
C2045831 (UMLS CUI [1,1])
Item
If yes: End of chemotherapy (month)
text
C0806020 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
CL.35
Code List
If yes: End of chemotherapy (month)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
CL Item
10 (10)
CL Item
11 (11)
CL Item
12 (12)
Year chemotherapy end
Item
If yes: End of chemotherapy (year)
integer
C0806020 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item Group
Previous botulinum toxin treatment
C0205156 (UMLS CUI [1,1])
C1321035 (UMLS CUI [1,2])
Previous BTX application
Item
Previous botulinum toxin application
boolean
C0205156 (UMLS CUI [1,1])
C1321035 (UMLS CUI [1,2])
Item
If yes: Indication
integer
C3146298 (UMLS CUI [1,1])
CL.8
Code List
If yes: Indication
CL Item
cosmetic treatment (1)
C0442965 (UMLS CUI [1,1])
CL Item
internal application (2)
C0205102 (UMLS CUI [1,1])
C0185125 (UMLS CUI [1,2])
Item
If yes: Result of test for neutralizing antibodies
integer
C1142254 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
CL.7
Code List
If yes: Result of test for neutralizing antibodies
CL Item
negative (1)
C0205160 (UMLS CUI [1,1])
CL Item
positive (2)
C1446409 (UMLS CUI [1,1])
CL Item
not done (3)
C1272696 (UMLS CUI [1,1])
Item Group
Pancreas-specific medical history
C0030274 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Item
Indication for planned surgery
integer
C3146298 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
CL.9
Code List
Indication for planned surgery
CL Item
pancreatic carcinoma (1)
C0235974 (UMLS CUI [1,1])
CL Item
cystic neoplasia (2)
C1333190 (UMLS CUI [1,1])
CL Item
chronic pancreatitis (3)
C0149521 (UMLS CUI [1,1])
CL Item
neuroendocrine tumor (4)
C0206695 (UMLS CUI [1,1])
CL Item
other (5)
C0205394 (UMLS CUI [1,1])
Specify
Item
If other indication, please specify
text
C1521902 (UMLS CUI [1,1])
Diabetes mellitus
Item
Preexisting diabetes mellitus
boolean
C2347662 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Insulin dependent
Item
If yes: Insulin dependent
boolean
C0011854 (UMLS CUI [1,1])
Preexisting exocrine insufficiency
Item
Preexisting exocrine insufficiency
boolean
C2347662 (UMLS CUI [1,1])
C0267963 (UMLS CUI [1,2])
Item Group
Prior / Concomitant Medication
C2826257 (UMLS CUI [1,1])
C2826666 (UMLS CUI [1,2])
Concomitant Medication intake
Item
Any Concomitant Medication intake?
boolean
C2826666 (UMLS CUI [1,1])
Item Group
If yes, please fill out eForm 'Concomitant Medication'
C2347852 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])
Item Group
Questionnaires
C0034394 (UMLS CUI [1,1])
EORTC QLQ-C30
Item
EORTC QLQ-C30 completed
boolean
C4055104 (UMLS CUI [1,1])
C1556116 (UMLS CUI [1,2])
EORTC QLQ-PAN26
Item
EORTC QLQ-PAN26 completed
boolean
C4288326 (UMLS CUI [1,1])
C1556116 (UMLS CUI [1,2])
Item Group
Randomization
C0034656 (UMLS CUI [1,1])
Date
Item
Date of Randomization
date
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Number
Item
Randomization number
integer
C1300638 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
Item
Randomization group
float
C0034656 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
CL.10
Code List
Randomization group
CL Item
preoperative endoscopic sphincter of Oddi BOTOX injection followed by distal pancreatectomy (intervention group) (1)
C2986530 (UMLS CUI [1,1])
C0445204 (UMLS CUI [2,1])
C0014245 (UMLS CUI [2,2])
C0028872 (UMLS CUI [2,3])
C0021485 (UMLS CUI [2,4])
C0700702 (UMLS CUI [2,5])
C0332157 (UMLS CUI [2,6])
C0332283 (UMLS CUI [2,7])
C0176940 (UMLS CUI [2,8])
CL Item
only distal pancreatectomy (control group) (2)
C0009932 (UMLS CUI [1,1])
C0176940 (UMLS CUI [2,1])
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