1 General part

2 Special part

2.1 Introduction

2.1.1 Objectives

2.2 Methods

2.2.1 Statisitcal analysis of the data

Pentru descrierea variabilelor cantitative am folosit histograme și am calculat mediile aritmetice ± deviația standard (DS) [cu intervalul de încredere (IC) 95%], precum și valorile extreme și mediane. Pentru variabilele calitative, am folosit pie-uri sau bar-chart-uri și am calculat frecvențele absolute și relative ale categoriilor formate.

Pentru a studia relațiile dintre variabilele cantitative și cele calitative, am folosit testele T și Mann-Whitney (MW) dacă acestea au fost binare, respectiv ANOVA dacă acestea au avut mai multe categorii. Am prezentat valorile p generate de aceste teste precum și mediile ± DS ale grupurilor și diferența mediilor cu IC95% asociat. Am prezentat grafic rezultatele sub forma unor box-plot-uri. Pentru a studia relațiile dintre variabilele cantitative am folosit coeficientul de corelație Spearman (R), cu valoarea p asociata și am prezentat grafic relațiile sub forma unor scatter-plot-uri pe care am adăugat linia de regresie cu IC95%. Pentru a descrie relațiile dintre variabilele calitative am folosit testul Chi2 sau Fisher și indicatorii Cramer phi sau V și Odds-Ratio (OR) / Risc relativ (RR) cu IC95%. Am prezentat grafic rezultatele sub forma unor bar-chart-uri.

Am folosit Microsot Excel 2016 pentru managementul bazei de date. Pentru toate analizele statistice și graficele ulterioare am folosit R 3.6.1 [1]. Am considerat p < 0.05 ca fiind semnificativ statistic și p < 0.1 ca prezentând doar o tendință spre semnificativitate statistică.

2.3 Results

2.3.1 Main

Table 1: Demographic parameters of the sample.

Variable

Details

Total

N=

231

Age (years)

μ ±SD

62.83 ±9.51

M (min:max)

63.25 (21.94:87.33)

Sex

F

94 (40.7%)

M

137 (59.3%)

Alive at 1-Oct-2019

95 (41.1%)

Place of living

rural

72 (34.8%)

urban

135 (65.2%)

State at discharge

cured

53 (24.7%)

ameliorated

145 (67.4%)

stationary

1 (0.5%)

agravated

4 (1.9%)

deceased

12 (5.6%)

Family history of cancer

10 (4.3%)

Survival time (years)

μ ±SD

2.40 ±1.77

M (min:max)

2.02 (0:6.61)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

Figure 1: Sex and place of living distribution.

Figure 2: Age distribution, at admission, colored by sex. (| media, ¦ mediana).

Figure 1: Sex and place of living distribution.

Figure 2: Age distribution, at admission, colored by sex. (| media, ¦ mediana).

2.3.2 Address

Figure 3: Distribuția geografică a cazurilor

2.3.3 Dates

2.3.4 Extra

Table 2:

Variable

Details

Total

N=

231

Operator

Dr. A. Bartos

88 (38.3%)

Dr. F. Zaharie

39 (17.0%)

Dr. C. Iancu

36 (15.7%)

Dr. N. Al Hajjar

22 (9.6%)

Dr. R. Bodea

22 (9.6%)

Dr. L. Mocan

10 (4.3%)

Dr. F. Graur

7 (3.0%)

Dr. F. Pop

3 (1.3%)

Dr. C. Tomus

1 (0.4%)

Dr. D. Munteanu

1 (0.4%)

Dr. G. Molnar

1 (0.4%)

Weight (kg)

μ ±SD

76.18 ±14.5

M (min:max)

75 (47:135)

Height (cm)

μ ±SD

170.10 ±8.33

M (min:max)

170 (143:190)

ASA score

0

18 (7.8%)

1

16 (6.9%)

2

152 (65.8%)

3

44 (19.0%)

4

1 (0.4%)

*PET-FDG

0

EDS

gut invasion

14 (17.7%)

no gut invasion

65 (82.3%)

Preoperative biliary decompression

endoscopic stentation

74 (32.0%)

cholecystostoma

19 (8.2%)

internal biliary derivation

12 (5.2%)

transparietohepatic drain

3 (1.3%)

none

123 (53.2%)

If preoperative biliary decompression, days to operation

μ ±SD

21.49 ±31.1

M (min:max)

13 (3:180)

Limph nodes - intraoperatory

invaded, removed

101 (49.0%)

not invaded

102 (49.5%)

3 (1.5%)

Metastasis

3 (1.4%)

Ascites

7 (3.3%)

Operation

cephalic duodenopancreatectomy

119 (53.6%)

cephalic duodenopancreatectomy
after biliary drainage

97 (43.7%)

cephalic duodenopancreatectomy
after stentation

6 (2.7%)

Principal bile duct diameter

μ ±SD

12.13 ±5.32

M (min:max)

12 (1:25)

Wirsung diameter

μ ±SD

4.32 ±2.3

M (min:max)

4 (0.2:15)

Pancreas texture

hard

86 (40.6%)

normal

65 (30.7%)

soft

61 (28.8%)

Surgery incidents

hemorrhage

7 (18.4%)

other organs lesions

2 (5.3%)

others

29 (76.3%)

Surgery duration (min)

μ ±SD

281.39 ±70.1

M (min:max)

270 (130:480)

Blood loss (mL)

μ ±SD

413.57 ±322.3

M (min:max)

350 (0:3000)

Transfusions (units)

0

177 (76.6%)

1

33 (14.3%)

2

16 (6.9%)

3

2 (0.9%)

4

2 (0.9%)

5

1 (0.4%)

Sandostatin profilaxis

60 (30.2%)

Reinterventions

14 (7.1%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

Figure 4:

Figure 5:

Figure 6:

Figure 7:

Figure 8:

Figure 9:

Figure 10:

Figure 11:

Figure 12:

Figure 13:

Figure 14:

Figure 15:

Figure 16:

Figure 17:

Figure 18:

2.3.5 Laboratory

Table 3: Laboratory parameters of the sample.

Variable

Details

Total

N=

231

Hemoglobin (mg/dL)

μ ±SD

11.75 ±2.32

M (min:max)

11.7 (7.96:16.4)

Leucocytes (*10³/µL)

μ ±SD

10.93 ±5.99

M (min:max)

8.64 (3.32:32.3)

Platelets (*10³/µL)

μ ±SD

281.55 ±102.6

M (min:max)

287.5 (74:595)

Sodium (mEq/L)

μ ±SD

142.59 ±3.5

M (min:max)

142 (131:160)

Potassium (mEq/L)

μ ±SD

5.02 ±0.768

M (min:max)

4.8 (3.6:8.8)

Calcium (mEq/L)

μ ±SD

4.62 ±0.382

M (min:max)

4.65 (3.13:5.61)

AST (IU/L)

μ ±SD

83.80 ±99.1

M (min:max)

70.5 (8:886)

ALT (IU/L)

μ ±SD

113.90 ±168.0

M (min:max)

78.5 (6:987)

Total bilirubin (mg/dL)

μ ±SD

4.30 ±3.48

M (min:max)

3.1 (0.3:18.5)

Direct bilirubin (mg/dL)

μ ±SD

3.79 ±3.39

M (min:max)

2.56 (0.14:14.04)

Alkaline phosphatase (IU/L)

μ ±SD

655.57 ±443.9

M (min:max)

672 (69:4086)

Gamma-GT (IU/L)

μ ±SD

376.90 ±410.1

M (min:max)

99 (7:3109)

Blood amylase (IU/L)

μ ±SD

112.75 ±185.8

M (min:max)

71.5 (2:965)

Urine amylase (IU/L)

μ ±SD

2891.77 ±6393.3

M (min:max)

66.5 (1:37578)

Urea (mg/dL)

μ ±SD

52.73 ±21.7

M (min:max)

51 (6:99)

Creatinine (mg/dL)

μ ±SD

1.13 ±0.841

M (min:max)

0.88 (0.36:8.93)

Total protein (mg/dL)

μ ±SD

7.08 ±0.949

M (min:max)

7.2 (4.3:9.7)

Prothrombin time (sec)

μ ±SD

24.29 ±8.12

M (min:max)

22.8 (14.5:76.7)

APTT (sec)

μ ±SD

51.98 ±27.1

M (min:max)

47.25 (23.2:83.7)

INR

μ ±SD

1.65 ±0.712

M (min:max)

1.5 (0.96:7.85)

CA 19-9 (ng/mL)

μ ±SD

205.61 ±598.7

M (min:max)

63.95 (1:5610)

ACE (ng/mL)

μ ±SD

10.55 ±23.0

M (min:max)

4 (0.9:121)

AFP (ng/mL)

μ ±SD

102.23 ±198.5

M (min:max)

3.7 (1.53:400)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

Figure 19: Laboratory paramenters.

2.3.6 Time to normalization

Table 4: Time to normalization parameters of the sample.

Variable

Details

Total

N=

231

Transit restart (days)

μ ±SD

3.32 ±0.939

M (min:max)

3 (1:7)

Mobilization (days)

μ ±SD

1.85 ±0.885

M (min:max)

2 (1:6)

Liquid alimentation restart (days)

μ ±SD

2.00 ±1.11

M (min:max)

2 (1:7)

Solid alimentation restart (days)

μ ±SD

3.46 ±1.32

M (min:max)

3 (1:10)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

Figure 20: Time to normalization, by sex.

2.4 Yes/No

2.4.1 Symptoms

Figure 21: Distribution of patients with any of the listed Symptoms.

Table 5: Distribution of patients with any of the listed Symptoms.

Variable

Total

N=

231

Pain

120 (51.9%)

Nausea

70 (30.3%)

Vomit

50 (21.6%)

Fatigability

85 (36.8%)

Asthenia

119 (51.5%)

Fever

10 (4.3%)

Loss of appetite

225 (97.4%)

Weight loss

153 (66.2%)

Diarrhea

13 (5.6%)

Melaena

4 (1.7%)

Hematemesis

0

None

9 (3.9%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.2 Signs

Figure 22: Distribution of patients with any of the listed Signs.

Table 6: Distribution of patients with any of the listed Signs.

Variable

Total

N=

231

Jaundice

167 (72.3%)

Hepatomegaly

8 (3.5%)

Courvoisier-Terrier

12 (5.2%)

Ascites

2 (0.9%)

Palpable tumor

1 (0.4%)

Phlebitis migrans (Trousseau sign?)

0

Ileus

0

Splenomegaly

0

Ecchymosis

0

None

32 (13.9%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.3 Comorbidities

Figure 23: Distribution of patients with any of the listed Comorbidities.

Table 7: Distribution of patients with any of the listed Comorbidities.

Variable

Total

N=

231

None / irrelevant

45 (19.5%)

Diabetes mellitus

45 (19.5%)

Vesicular lithiasis

30 (13.0%)

Cardio-vascular disease

99 (42.9%)

Lung disease

16 (6.9%)

Liver disease

18 (7.8%)

Kidney disease

10 (4.3%)

Cancer

11 (4.8%)

Others

43 (18.6%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.4 Toxics

Figure 24: Distribution of patients with any of the listed Toxics.

Table 8: Distribution of patients with any of the listed Toxics.

Variable

Total

N=

231

None / deny

141 (61.0%)

Alcohol

53 (22.9%)

Smoking

44 (19.0%)

Nitrosamines

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.5 Ultrasound

Figure 25: Distribution of patients with any of the listed Ultrasound.

Table 9: Distribution of patients with any of the listed Ultrasound.

Variable

Total

N=

231

Veins invasion

3 (1.3%)

Arteries invasion

1 (0.4%)

Gut invasion

4 (1.7%)

Tumor < 4 cm

94 (40.7%)

Lymphadenopathy

26 (11.3%)

Liver metastases

0

Peritoneal metastases

0

Ascites

1 (0.4%)

Dilated bile ducts

80 (34.6%)

Inhomogeneous pancreas

26 (11.3%)

Fluid sequestration

0

Abscesses

0

Pancreatic fluid collections

0

Wirsung lithiasis

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.6 Abdominal CT

Figure 26: Distribution of patients with any of the listed Abdominal CT.

Table 10: Distribution of patients with any of the listed Abdominal CT.

Variable

Total

N=

231

Veins invasion

10 (4.3%)

Arteries invasion

3 (1.3%)

Gut invasion

6 (2.6%)

Tumor < 4 cm

104 (45.0%)

Lymphadenopathy

57 (24.7%)

Liver metastases

1 (0.4%)

Peritoneal metastases

0

Ascites

2 (0.9%)

Dilated bile ducts

81 (35.1%)

Inhomogeneous pancreas

35 (15.2%)

Fluid sequestration

0

Abscesses

1 (0.4%)

Pancreatic fluid collections

0

Wirsung lithiasis

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.7 MRI

Figure 27: Distribution of patients with any of the listed MRI.

Table 11: Distribution of patients with any of the listed MRI.

Variable

Total

N=

231

Veins invasion

1 (0.4%)

Arteries invasion

0

Gut invasion

1 (0.4%)

Tumor < 4 cm

23 (10.0%)

Lymphadenopathy

12 (5.2%)

Liver metastases

0

Peritoneal metastases

0

Ascites

0

Dilated bile ducts

21 (9.1%)

Inhomogeneous pancreas

10 (4.3%)

Fluid sequestration

0

Abscesses

0

Pancreatic fluid collections

0

Wirsung lithiasis

1 (0.4%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.8 Selective angiography

Figure 28: Distribution of patients with any of the listed Selective angiography.

Table 12: Distribution of patients with any of the listed Selective angiography.

Variable

Total

N=

231

Portal vein invasion

2 (0.9%)

Superior mesenteric vein invasion

0

Confluent invasion

0

Celiac trunk invasion

0

Superior mesenteric artery invasion

0

Common hepatic artery invasion

0

Splenic artery invasion

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.9 MR angiography

Figure 29: Distribution of patients with any of the listed MR angiography.

Table 13: Distribution of patients with any of the listed MR angiography.

Variable

Total

N=

231

Portal vein invasion

1 (0.4%)

Superior mesenteric vein invasion

1 (0.4%)

Confluent invasion

1 (0.4%)

Celiac trunk invasion

0

Superior mesenteric artery invasion

0

Common hepatic artery invasion

0

Splenic artery invasion

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.10 MR Cholangiopancreatography

Figure 30: Distribution of patients with any of the listed MR Cholangiopancreatography.

Table 14: Distribution of patients with any of the listed MR Cholangiopancreatography.

Variable

Total

N=

231

Principal bile ducts dilation

23 (10.0%)

Intrahepatic bile ducts dilation

17 (7.4%)

Principal bile ducts obstruction

15 (6.5%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.11 ERCP

Figure 31: Distribution of patients with any of the listed ERCP.

Table 15: Distribution of patients with any of the listed ERCP.

Variable

Total

N=

231

Visible tumor

52 (22.5%)

Biopsy

45 (19.5%)

Intrahepatic bile ducts dilation

46 (19.9%)

Stent

78 (33.8%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.12 Echoendoscopy

Figure 32: Distribution of patients with any of the listed Echoendoscopy.

Table 16: Distribution of patients with any of the listed Echoendoscopy.

Variable

Total

N=

231

Veins invasion

4 (1.7%)

Arteries invasion

3 (1.3%)

Gut invasion

63 (27.3%)

Tumor < 4 cm

6 (2.6%)

Lymphadenopathy

19 (8.2%)

Biopsy

34 (14.7%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.13 Laparoscopy

Figure 33: Distribution of patients with any of the listed Laparoscopy.

Table 17: Distribution of patients with any of the listed Laparoscopy.

Variable

Total

N=

231

Biopsy

0

Lavaj-citologie

0

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.14 Adjacent organ invasion

Figure 34: Distribution of patients with any of the listed Adjacent organ invasion.

Table 18: Distribution of patients with any of the listed Adjacent organ invasion.

Variable

Total

N=

231

Stomach

1 (0.4%)

Duoden

14 (6.1%)

Transverse colon

1 (0.4%)

Transverse mesocolon

2 (0.9%)

Spleen

0

Kidney

0

Other

2 (0.9%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.15 Vascular invasion

Figure 35: Distribution of patients with any of the listed Vascular invasion.

Table 19: Distribution of patients with any of the listed Vascular invasion.

Variable

Total

N=

231

Portal vein

18 (7.8%)

Superior mesenteric vein

10 (4.3%)

Confluent

3 (1.3%)

Celiac trunk

0

Superior mesenteric artery

4 (1.7%)

Common hepatic artery

0

Splenic artery

0

Other

1 (0.4%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.16 Associated operations

Figure 36: Distribution of patients with any of the listed Associated operations.

Table 20: Distribution of patients with any of the listed Associated operations.

Variable

Total

N=

231

Wedger venous resection

15 (6.5%)

Segmentar venous resection

9 (3.9%)

Liver resection

1 (0.4%)

Other

11 (4.8%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.17 Tratament bont pancreatic

Figure 37: Distribution of patients with any of the listed Tratament bont pancreatic.

Table 21: Distribution of patients with any of the listed Tratament bont pancreatic.

Variable

Total

N=

231

Wirsung occlusion

0

Tratament bont pancreatic - Pancreaticogastrostomy

143 (61.9%)

Tratament bont pancreatic - Pancreaticojejunostomy

23 (10.0%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.18 Complications

Figure 38: Distribution of patients with any of the listed Complications.

Table 22: Distribution of patients with any of the listed Complications.

Variable

Total

N=

231

Pancreatic fistula

16 (6.9%)

Bile ducts fistula

7 (3.0%)

Digestive fistula

3 (1.3%)

Hemorrhage

11 (4.8%)

Gastric stasis

24 (10.4%)

Pancreatita bont

3 (1.3%)

Peritonits

1 (0.4%)

Suppuration

22 (9.5%)

Intraperitoneala hemorrhage

2 (0.9%)

Septic shock

1 (0.4%)

Pulmonar

8 (3.5%)

Cardiovascular

10 (4.3%)

Hepatic

4 (1.7%)

Other

22 (9.5%)

μ ±SD = Mean (standard deviation); M (min:max) = Median (min:max);

2.4.19 Simptoms

2.4.20 Signs

2.4.21 Comorbidities

2.4.22 Toxics

2.4.23 Ultrasound

2.4.24 Abdominal CT

2.4.25 MRI

2.4.26 Selective angiography

2.4.27 MR angiography

2.4.28 MR Cholangiopancreatography

2.4.29 ERCP

2.4.30 Echoendoscopy

2.4.31 Laparoscopy

2.4.32 Acute pancreatitis

2.4.33 Adjacent organ invasion

2.4.34 Vascular invasion

2.4.35 Associated operations

2.4.36 Tratament bont pancreatic

2.4.37 Complications

3 References

  1. R Core Team (2019). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.