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
Gender
integer
C0079399 (UMLS CUI [1,1])
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])
Code List
Result of pregnancy test
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])
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])
Previous abdominal surgery
Item
Previous abdominal surgery
boolean
C0262926 (UMLS CUI [1,1])
C0198482 (UMLS CUI [1,2])
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])
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])
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
Smoking
integer
C1519386 (UMLS CUI [1,1])
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 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
ASA
integer
C1531480 (UMLS CUI [1,1])
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])
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])
Code List
If yes: End of radiotherapy (month)
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])
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])
Code List
If yes: End of chemotherapy (month)
Year chemotherapy end
Item
If yes: End of chemotherapy (year)
integer
C0806020 (UMLS CUI [1,1])
C0439234 (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])
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])
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
Indication for planned surgery
integer
C3146298 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
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])
Concomitant Medication intake
Item
Any Concomitant Medication intake?
boolean
C2826666 (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])
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])
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])