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`Table 1 Number of patients.
`New hemoszauc
`agent
`8
`
`8 teases»
`
`25
`56
`89
`
`13
`32
`37
`
`Acme hepamis
`Chron‘c '
`t‘
`le;$&§e
`Chronic acti e
`hepatitvis
`Liver cirrhosis
`He ate
`:1
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`Metastatic
`liver cancer
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`Ge$atin
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`0
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`22
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`
`Gastroenterol. Enclose. 30 2 2249~2256, 1988
`Shinobu SAKURABAYASHI
`
`Clinical evaluation of new hemostatic agent for hemostasis
`from biopsy in the liver.
`
`O
`O
`2
`2
`0
`0
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`Fatty liver
`14
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`Total
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`183
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`107
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`23
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`53
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`Gastroenterological Endoscopy
`
`ETHICON EXHIBIT 1015
`
`ETHICON EXHIBIT 1015
`
`

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`Figure 1 New hemastntic agent.
`
`Srzvumars
`media
`
`
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`..
`
`
`
`Needle :5
`rammed 3m
`3&3 mama:
`
`Figure 2 Tam different hemostatic procednrea with
`the use 9f New hemastatic agent.
`
`Table 2 Camposition 0f New hemostatic agent and coagulatian pathway.
`
`Compositian cf New hemostatic agent
`
`Gefiatin 3:10“!er
`
`Thrombin
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`Factar X!!!
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`{insalubie}
`{sotuble}
`
`j
`
`Gamroentemlagical Endoscgpy
`
`

`

`Vol. 30(10), Oct. 1988
`
`We
`
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`
`2251
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`Table 3 Comparison between two different hemostatic procedures with the use of
`New hemostatic agent and control in hemostatie time.
`
`Hemostatic time"
`
`Hemostatic
`method
`abiiity
`
`
`Hemostatic
`
`
`
`
`
`Method A
`80 cases
`
`*iit'w— ishow the grade of hemostatic time
`
`Table 4 Comparison between two different hemostatic procedures with
`the use of New hemostatic agent and control in hemostatic situation.
`
`Hemostanc
`SKuation
`
`Hemostatic
`method
`
`Method A
`80 cases
`
`
`
`
`
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`
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`
`
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`Control
`43
`
`2( 7)
`
`0
`
`16(37)
`
`6(14)
`
`Gastroenterological Endoscopy
`
`

`

`2252
`
`191%
`
`1531*
`
`.58
`
`131%
`
`Vol. 30(10), Oct. 1988
`
`Table 5 Comparison between New hemostatic agent,
`gelatin-sponge and control in fever after biopsy.
`Once biopsy
`
`Table 7 Comparison between New hemostatic agent,
`gelatimsponge and control in period of suffering hypo-
`chondralgia after biopsy.
`
`New hemostatic agent (33cases) 37.98 i 1.06 CC)
`Gelatin-sponge
`(14)
`37.72 i: 097
`Control
`(34)
`37.50 i: 0.77
`Twice biopsy
`
`New hemostatic agent (190ases) 38.01 i 0.58 (°C)
`Gelatin-sponge
`(9)
`37.92 :1: 0.44
`Control
`(19)
`37.66 i: 0.62
`
`Table 6 Comparison between New hemostatic
`agent, gelatin-sponge and control in period of suffer-
`ing fever after biopsy.
`
`Once biopsy
`
`New hemostatic agent (330ases)
`Gelatin-sponge
`(14)
`Control
`(34)
`Twice biopsy
`
`2,4 :1: 23 (day)
`2.4 i 2.7
`2.5 :i: 3.0
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`( 9)
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`
`2.8 i 1.7(day)
`2.2 i 1.1
`
`2.3 i 2.4
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`Once biopsy
`
`New hemostatic agent (330ases)
`Gelatin-sponge
`(14)
`Control
`(34)
`
`3.4 3L. 2.2 (day)
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`3.1 i 2.6
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`Twice biopsy
`
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`(9)
`Control
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`Gastroenterological Endoscopy
`
`

`

`V01. 30(10), Oct. 1988
`
`Wfi
`
`&% E 03 25>
`
`2253
`
`Table 8 Comparison between New hemostatic agent, gelatin-sponge and
`control in elevation of S-GPT after biopsy.
`
`Once biopsy
`
`Hemostatic agent
`
`Elevation of S~GPT
`
`190m)
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`
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`Ge}atin-sponge
`Control
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`Gastroenterological Endoscopy
`
`

`

`2254
`
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`Gastroenterological Endoscopy
`
`

`

`2256
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`65%
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`Vol. 30(10), Oct. 1988
`
`CLINICAL EVALUATION OF NEW HEMOSTATIC AGENT
`
`FOR HEMOSTASIS FROM BIOPSY WOUNDS IN THE LIVER
`
`Shinobu SAKURABAYASHI, Hitoshi YOSHIMASU,
`
`Jun SHIMIZU,
`
`Fukashi SUGIURA, Yoshinori NISHIZATO, Toshihiko SAITO,
`AND Shinroku ASHIZAWA
`
`The Fourth Department of Internal Medicine, Tokyo Medical College.
`
`The hemostatic effect of new hemostatic agent, consisting of gelatin powder, human
`
`thrombin and XIII clotting factor, was evaluated by hepatic biopsy of the cases with
`
`hepatic disease. The Studied cases were 107 in elusive of S—acute hepatitis; lB-chronic
`
`inactive hepatitis ; 32—chronic active hepatitis ; 37-cirrhosis; 2—hepatoma ; 3—-metastatic
`
`carcinoma of liver;4—-primary biliary cirrhosis;and 8—fatty liver. Two hemostatic
`
`methods adopted. In A-method by which a Silverman needle is extracted up to the hepatic
`
`surface after biopsy, 2ml of new hemostatic agent is injected and a bioptic needle is
`
`retained for a minute.
`
`In B-method by which a Silverman needle is extracted up to lcm
`
`from the hepatic surface after biopsy, 1ml of this agent is injected, further 1ml is injected
`
`at a position of 5mm from the hepatic surface and a biopsy needle is retained for 30
`
`seconds. As a result, no significant difference was observed between A and B methods with
`
`new hemostatic agent, showing evidently shortened hemostatic time and favorable hemos—
`
`tatic condition, compared with the control group in which no hemostatic agent was used.
`
`Complete hemostasis was attained particularly in 2 cases of hepatoma and 3 cases of
`
`metastatic carcinoma of liver on which tumor biopsies were performed. Then, adverse
`
`effect after biopsy was investigated comparatively among groups of new hemostatic agent,
`
`gelatin-sponge and control by number of biopsy. No significant adverse effect was
`
`observed in this agent in the assessments of pyrexia after biopsy, number of pyrexial days,
`
`number of days with pain and rise in S-GPT. Thus, it was presumed that new hemostatic
`
`agent is of a very high usefulness as a hemostatic agent for hepatic biopsy.
`
`(ha-film)
`
`Figure 3 Classification of hemostatic situation in the liver surface.
`(75 e—isata : p. 2241)
`
`Gastroenterological Endoscopy
`
`

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