ID

45872

Beskrivning

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

Nyckelord

Botulinum Toxins

D009803

D010185

26/10/2023 26/10/2023 - Nelly Zental

Rättsinnehavare

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

Uppladdad den

26 de outubro de 2023

DOI

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Licens

Creative Commons BY 4.0

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PREBOT trial

model
Detaljer

Visit 1: Enrollment and Randomization

13 Formulär

StudyEvent: PREBOT Pilot
StudyEvent: Complications
1. Complications
StudyEvent: Readmission To Hospital (repeatable instrument)
1. Readmission To Hospital (repeatable instrument)
StudyEvent: Adverse Events (repeatable instrument)
1. Adverse Events (repeatable instrument)
StudyEvent: Concomitant Medication
1. Concomitant Medication
StudyEvent: Protocol Violation (repeatable instrument)
1. Protocol Violation (repeatable instrument)
StudyEvent: Patient report: EORTC QLQ-C30
StudyEvent: Patient report: EORTC QLQ-PAN26

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Screening

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])

Demographic data

Item Group

Demographic data

C1704791 (UMLS CUI [1,1])

Gender

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])

pregnancy test

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)

Inclusion

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])

Exclusion

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])

Baseline clinical data

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])

Specify

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])

Type

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])

Relevant prior / concomitant diseases

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])

Smoking & Alcohol

Item Group

Smoking and Alcohol

C0001948 (UMLS CUI [1,1])
C0037369 (UMLS CUI [1,2])

Smoking

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])

Alcohol abuse

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])

ASA

Item Group

ASA Score

C1531480 (UMLS CUI [1,1])

ASA

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])

Previous radio-/ chemotherapy

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])

Month radiotherapy end

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])

Chemotherapy regime

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])

Month chemotherapy end

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])

Previous BTX treatment

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])

Indication

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])

Testresult Antibodies

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])

Pancreas-specific medical history

Item Group

Pancreas-specific medical history

C0030274 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])

Indication

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])

Prior / Concomitant Medication

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])

eForm 'Concomitant Medication'

Item Group

If yes, please fill out eForm 'Concomitant Medication'

C2347852 (UMLS CUI [1,1])
C3273494 (UMLS CUI [1,2])

Questionnaires

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])

Randomization

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])

Group

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])

Tillbaka till toppen

ID

Beskrivning

Nyckelord

Versioner (1)

Rättsinnehavare

Uppladdad den

DOI

Licens

Modellkommentarer :

Itemgroup-kommentar för :

Item-kommentar för :

PREBOT trial

Visit 1: Enrollment and Randomization

Beskrivning

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