ID

45592

Beskrivning

Duodenum-preserving head resection versus pancreatico-duodenectomy for chronic pancreatitis of the head. Study Center of the German Surgical Society (SDGC) Trial protocol of a randomised controlled multicentre trial. Trials. 2010 Apr 29;11:47. doi: 10.1186/1745-6215-11-47. PMID: 20429912; PMCID: PMC2874785. Controlled-trials.com ISRCTN38973832

Länk

Publication

Nyckelord

Versioner (1)
  1. 06.02.23 06.02.23 - Dr. Christian Niklas
Rättsinnehavare

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mössner J, Kieser M, Werner J, Büchler MW, Seiler CM

Uppladdad den

6. Februar 2023

DOI

10.1186/1745-6215-11-47

Licens

Creative Commons BY 4.0
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ChroPac-trial: duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis

Engelsk

Start Questionnaire

7 Formulär  
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Date of Visit
Beskrivning

Date of Visit

Alias
UMLS CUI [1,1]
C1320303
please enter the date of the first visit
Beskrivning

Date of first Visit

Datatyp

date

Alias
UMLS CUI [1,1]
C1320303
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI [1,1]
C1512693
Patient is scheduled for primary surgery for chronic headpancreatitis
Beskrivning

scheduled for primary surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3242215
Ability to understand character and individual consequences of the clinical trial
Beskrivning

Ability to understand

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
Written informed consent
Beskrivning

Written consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
Date of written informed consent:
Beskrivning

Date of consent

Datatyp

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI [1,1]
C0680251
Participation in another intervention-trial with interference of intervention and outcome of this study
Beskrivning

Participation in another intervention-trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521115
UMLS CUI [1,3]
C0814861
Quality of Life
Beskrivning

Quality of Life

Alias
UMLS CUI [1,1]
C0034380
EORTC QLQ-C30 form completed
Beskrivning

QLQ-C30 form

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
EORTC QLQ-PAN26 form completed
Beskrivning

QLQ-PAN26

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3476431
Demography
Beskrivning

Demography

Alias
UMLS CUI [1,1]
C0011298
Gender
Beskrivning

Gender

Datatyp

integer

Alias
UMLS CUI [1,1]
C0079399
Age
Beskrivning

Age

Datatyp

integer

Måttenheter
  • year
Alias
UMLS CUI [1,1]
C0001779
year
Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
Alias
UMLS CUI [1,1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C0005910
kg
Baseline Clinical Data
Beskrivning

Baseline Clinical Data

Alias
UMLS CUI [1,1]
C1442488
UMLS CUI [1,2]
C1516606
Smoking History
Beskrivning

Smoking History

Datatyp

integer

Alias
UMLS CUI [1,1]
C1519384
cigarettes per day
Beskrivning

cigarettes per day

Datatyp

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C3694146
number of years
Beskrivning

years smoking

Datatyp

integer

Alias
UMLS CUI [2,1]
C1265611
UMLS CUI [2,2]
C0439234
UMLS CUI [2,3]
C0543414
stopped in year
Beskrivning

stopped in year

Datatyp

date

Alias
UMLS CUI [1,1]
C0425310
UMLS CUI [1,2]
C0439234
Alcohol Consumption
Beskrivning

Alcohol Consumption

Datatyp

integer

Alias
UMLS CUI [1,1]
C0001948
stopped in year
Beskrivning

stopped in year

Datatyp

integer

Alias
UMLS CUI [1,1]
C0425321
UMLS CUI [1,2]
C0439234
please specify
Beskrivning

specify

Datatyp

integer

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0001948
Duration of Chronic Pancreatitis Related Symptoms
Beskrivning

Duration of Chronic Pancreatitis Related Symptoms

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0149521
Pain
Beskrivning

Pain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030193
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
months
Indigestion
Beskrivning

Indigestion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013395
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0013395
months
Weight loss
Beskrivning

Weight loss

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1262477
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C1262477
months
weight loss
Beskrivning

weight loss

Datatyp

integer

Måttenheter
  • kg
Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439209
kg
Diabetes Mellitus (under current oral or s.c. medication)
Beskrivning

Diabetes Mellitus

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0013216
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0011849
months
Exocrine insufficiency (continuous supplement of enzymes necessary)
Beskrivning

Exocrine insufficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0267963
UMLS CUI [1,2]
C0948571
please specify duration
Beskrivning

duration

Datatyp

integer

Måttenheter
  • months
Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C0439231
UMLS CUI [1,3]
C0267963
UMLS CUI [1,4]
C0948571
months
Imaging Techniques
Beskrivning

Imaging Techniques

Alias
UMLS CUI [1,1]
C0011923
Patient had CT
Beskrivning

CT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0040405
Patient had MRT
Beskrivning

MRT

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024485
Results of preoperative imaging studies
Beskrivning

Results of preoperative imaging studies

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C1881134
UMLS CUI [1,3]
C1274040
Pancreatic head enlargement
Beskrivning

Pancreatic head enlargement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3149699
Presence of calcification in the pancreas
Beskrivning

pancreas calcification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0747173
Enlargement of the common bile duct
Beskrivning

Enlargement common bile duct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020564
UMLS CUI [1,2]
C0009437
Enlargement of the pancreatic duct
Beskrivning

Enlargement of the pancreatic duct

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020564
UMLS CUI [1,2]
C0030288
Compression of retropancreatic vessels
Beskrivning

Compression retropancreatic vessels

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0227594
UMLS CUI [1,2]
C3160813
Results of Preoperative Endoscopy
Beskrivning

Results of Preoperative Endoscopy

Alias
UMLS CUI [1,1]
C0445204
UMLS CUI [1,2]
C0014245
UMLS CUI [1,3]
C1274040
Duodenal obstruction
Beskrivning

Duodenal obstruction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013292
Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)
Beskrivning

Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)

Alias
UMLS CUI [1,1]
C1561548
UMLS CUI [1,2]
C0008310
Frequency of ERCP
Beskrivning

Frequency of ERCP

Datatyp

string

Alias
UMLS CUI [1,1]
C1561548
UMLS CUI [1,2]
C0008310
Number of pancreatic stent implantation
Beskrivning

number pancreatic stents

Datatyp

integer

Alias
UMLS CUI [1,1]
C0183516
UMLS CUI [1,2]
C0449958
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Similar models

Start Questionnaire

7 Formulär
  1. StudyEvent: Visit 1 : Screening
    1. Start Questionnaire
  2. StudyEvent: Visit 2 : Operation
    1. Start Questionnaire
  3. StudyEvent: Visit 3: Discharge
    1. Start Questionnaire
  4. StudyEvent: Visit 4: 6 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  5. StudyEvent: Visit 5: 12 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  6. StudyEvent: Visit 6: 24 +/- 1 Months Post Randomisation
    1. Start Questionnaire
  7. StudyEvent: End of Study
    1. Start Questionnaire
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Date of Visit
C1320303 (UMLS CUI [1,1])
Date of first Visit
Item
please enter the date of the first visit
date
C1320303 (UMLS CUI [1,1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI [1,1])
scheduled for primary surgery
Item
Patient is scheduled for primary surgery for chronic headpancreatitis
boolean
C3242215 (UMLS CUI [1,1])
Ability to understand
Item
Ability to understand character and individual consequences of the clinical trial
boolean
C0021430 (UMLS CUI [1,1])
Written consent
Item
Written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
Date of consent
Item
Date of written informed consent:
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI [1,1])
Participation in another intervention-trial
Item
Participation in another intervention-trial with interference of intervention and outcome of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0814861 (UMLS CUI [1,3])
Item Group
Quality of Life
C0034380 (UMLS CUI [1,1])
QLQ-C30 form
Item
EORTC QLQ-C30 form completed
boolean
C3476431 (UMLS CUI [1,1])
QLQ-PAN26
Item
EORTC QLQ-PAN26 form completed
boolean
C3476431 (UMLS CUI [1,1])
Item Group
Demography
C0011298 (UMLS CUI [1,1])
Item
Gender
integer
C0079399 (UMLS CUI [1,1])
CL.1
Code List
Gender
CL Item
male (0)
C0086582 (UMLS CUI [1,1])
CL Item
female (1)
C0086287 (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])
Item Group
Baseline Clinical Data
C1442488 (UMLS CUI [1,1])
C1516606 (UMLS CUI [1,2])
Item
Smoking History
integer
C1519384 (UMLS CUI [1,1])
CL.2
Code List
Smoking History
CL Item
Non-smoker (0)
C0337672 (UMLS CUI [1,1])
CL Item
Current smoker (1)
C3241966 (UMLS CUI [1,1])
CL Item
Previous-smoker (2)
C0337671 (UMLS CUI [1,1])
cigarettes per day
Item
cigarettes per day
integer
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
years smoking
Item
number of years
integer
C1265611 (UMLS CUI [2,1])
C0439234 (UMLS CUI [2,2])
C0543414 (UMLS CUI [2,3])
stopped in year
Item
stopped in year
date
C0425310 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Alcohol Consumption
integer
C0001948 (UMLS CUI [1,1])
CL.3
Code List
Alcohol Consumption
CL Item
never (0)
C2136009 (UMLS CUI [1,1])
CL Item
current consumption (1)
C0001948 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
CL Item
previous consumption (2)
C4745093 (UMLS CUI [1,1])
stopped in year
Item
stopped in year
integer
C0425321 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
please specify
integer
C1521902 (UMLS CUI [1,1])
C0001948 (UMLS CUI [1,2])
CL.4
Code List
please specify
CL Item
Sporadic: 1 or 2 glasses of wine / beer per day up to 2 drinks per week (0)
C0205422 (UMLS CUI [1,1])
CL Item
Regular: 3 glasses of wine / beer per day or 20 drinks per week, patient is able to stop daily consumption (1)
C0205272 (UMLS CUI [1,1])
CL Item
Excessive: more than 3 glasses of wine / beer per day or more than 20 drinks per week, patient is unable to stop daily consumption (2)
C0442802 (UMLS CUI [1,1])
Item Group
Duration of Chronic Pancreatitis Related Symptoms
C0449238 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0149521 (UMLS CUI [1,3])
Pain
Item
Pain
boolean
C0030193 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
Indigestion
Item
Indigestion
boolean
C0013395 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0013395 (UMLS CUI [1,3])
Weight loss
Item
Weight loss
boolean
C1262477 (UMLS CUI [1,1])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C1262477 (UMLS CUI [1,3])
weight loss
Item
weight loss
integer
C1262477 (UMLS CUI [1,1])
C0439209 (UMLS CUI [1,2])
Diabetes Mellitus
Item
Diabetes Mellitus (under current oral or s.c. medication)
boolean
C0011849 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0011849 (UMLS CUI [1,3])
Exocrine insufficiency
Item
Exocrine insufficiency (continuous supplement of enzymes necessary)
boolean
C0267963 (UMLS CUI [1,1])
C0948571 (UMLS CUI [1,2])
duration
Item
please specify duration
integer
C0449238 (UMLS CUI [1,1])
C0439231 (UMLS CUI [1,2])
C0267963 (UMLS CUI [1,3])
C0948571 (UMLS CUI [1,4])
Item Group
Imaging Techniques
C0011923 (UMLS CUI [1,1])
CT
Item
Patient had CT
boolean
C0040405 (UMLS CUI [1,1])
MRT
Item
Patient had MRT
boolean
C0024485 (UMLS CUI [1,1])
Item Group
Results of preoperative imaging studies
C0445204 (UMLS CUI [1,1])
C1881134 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Pancreatic head enlargement
Item
Pancreatic head enlargement
boolean
C3149699 (UMLS CUI [1,1])
pancreas calcification
Item
Presence of calcification in the pancreas
boolean
C0747173 (UMLS CUI [1,1])
Enlargement common bile duct
Item
Enlargement of the common bile duct
boolean
C0020564 (UMLS CUI [1,1])
C0009437 (UMLS CUI [1,2])
Enlargement of the pancreatic duct
Item
Enlargement of the pancreatic duct
boolean
C0020564 (UMLS CUI [1,1])
C0030288 (UMLS CUI [1,2])
Compression retropancreatic vessels
Item
Compression of retropancreatic vessels
boolean
C0227594 (UMLS CUI [1,1])
C3160813 (UMLS CUI [1,2])
Item Group
Results of Preoperative Endoscopy
C0445204 (UMLS CUI [1,1])
C0014245 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Duodenal obstruction
Item
Duodenal obstruction
boolean
C0013292 (UMLS CUI [1,1])
Item Group
Frequency of ERCP (Endoscopic Retrograde Cholangio Pancreaticography)
C1561548 (UMLS CUI [1,1])
C0008310 (UMLS CUI [1,2])
Frequency of ERCP
Item
Frequency of ERCP
string
C1561548 (UMLS CUI [1,1])
C0008310 (UMLS CUI [1,2])
number pancreatic stents
Item
Number of pancreatic stent implantation
integer
C0183516 (UMLS CUI [1,1])
C0449958 (UMLS CUI [1,2])
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