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1 Department of Radiology, Osaka City University Graduate School of Medicine,
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan.
2 Department of Radiology, Faculty of Medicine, Tottori University, Tottori,
Japan.
3 Department of Gastroenterology, Osaka City University Graduate School of
Medicine, Osaka, Japan.
Received September 5, 2003;
accepted after revision February 17, 2004.
Address correspondence to T. Ninoi
(ninoi{at}msic.med.osaka-cu.ac.jp).
Abstract
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MATERIALS AND METHODS. A total of 139 cirrhotic patients with gastric varices underwent endovascular treatment. Of the 139 patients, 104 without hepatocellular carcinoma were enrolled; 27 patients were treated with TIPS, and 77 patients with transcatheter sclerotherapy. Bleeding of gastric varices and survival rates were compared between the TIPS and transcatheter sclerotherapy groups. Multivariate analysis was used to identify the prognostic factors for gastric variceal bleeding and survival. Changes in liver function were evaluated in each group.
RESULTS. The cumulative gastric variceal bleeding rate at 1 year was 20% in the TIPS group and 2% in the transcatheter sclerotherapy group (p < 0.01). The prognostic factor associated with gastric variceal bleeding was the treatment method. The cumulative survival rates at 1, 3, and 5 years were, respectively, 81%, 64%, and 40% in the TIPS group and 96%, 83%, and 76% in the transcatheter sclerotherapy group (p < 0.01). The prognostic factors for survival were the treatment method and the Child-Pugh classification of liver disease. For patients categorized in Child-Pugh class A, the survival rate was higher in the transcatheter sclerotherapy group than in the TIPS group (p < 0.01). For patients in Child-Pugh classes B and C, no significant difference was seen between the two groups. Liver function tended to improve in the transcatheter sclerotherapy group.
CONCLUSION. Transcatheter sclerotherapy may provide better control of gastric variceal bleeding than TIPS. Transcatheter sclerotherapy may contribute to a higher survival rate than TIPS in patients with Child-Pugh class A disease.
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The transjugular intrahepatic portosystemic shunt (TIPS) has been widely accepted as an effective treatment for esophagogastric varices since its first clinical application in 1988 [6, 7]. TIPS is less invasive than a surgical shunt, and the surgical mortality rate (1%) is lower than that of surgical shunts (3–15%) [8, 9]. TIPS is recognized as a safe and effective decompression therapy for portal hypertension [8–13].
Transcatheter sclerotherapy is classified into retrograde transcatheter sclerotherapy and antegrade transcatheter sclerotherapy. As for retrograde transcatheter sclerotherapy, balloon-occluded retrograde transvenous obliteration (B-RTO) has been widely performed in patients with gastric varices in Japan [14–20] after being reported by Kanagawa et al. [21, 22] in 1991. In Japan, B-RTO is recognized as a safe and effective treatment for gastric varices with a gastrorenal shunt. However, not all gastric varices are curable by B-RTO. Some gastric varices without a gastrorenal shunt are difficult to treat by B-RTO. With respect to antegrade transcatheter sclerotherapy, at our hospital percutaneous transhepatic sclerotherapy has been performed for gastric varices with no gastrorenal shunt. Percutaneous transhepatic sclerotherapy is the new procedure, which differs from conventional percutaneous transhepatic obliteration in using a sclerosant and metallic coils [23–25]. Percutaneous transhepatic sclerotherapy is the same as B-RTO in that gastric varices are sclerosed.
The effects on portal pressure differ completely in TIPS and transcatheter sclerotherapy. However, to our knowledge, no comparative study of the two treatments has been reported. The objective of this retrospective study was to compare TIPS with transcatheter sclerotherapy for treatment of bleeding gastric varices and for survival after treatment.
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In patients in the transcatheter sclerotherapy group, draining veins of gastric varices were evaluated using contrast-enhanced CT before the procedure, which determined a choice between B-RTO and percutaneous transhepatic sclerotherapy. The indication for B-RTO was gastric varices with a gastrorenal shunt. The indication for percutaneous transhepatic sclerotherapy was gastric varices without a gastrorenal shunt, gastric varices with gastrorenal and gastrocaval shunts, and gastric varices untreated by B-RTO. Of the 77 patients in the transcatheter sclerotherapy group, 49 patients were treated by B-RTO and 28 patients by percutaneous transhepatic sclerotherapy.
Techniques
TIPS was performed via the right jugular vein using a Rosch-Uchida
transjugular liver access set (Cook). An artificial shunt was created between
the right hepatic vein and the portal vein using a stent with a diameter of 8
or 10 mm (Wallstent, Boston Scientific). For patients who had no morphologic
change in gastric varices, additional coil embolizations without the use of a
sclerosant were performed for feeding veins via the TIPS tract.
B-RTO was performed in the following manner (Fig. 1A): First, a 6 French-balloon catheter with a diameter of 10 or 20 mm (MOIYAN, Miyano) was inserted into the gastrorenal shunt via the right femoral vein. Retrograde venography was performed with the balloon inflated. When retrograde venography revealed visualization of the gastric varices, and fluoroscopy after retrograde venography showed retention of contrast medium in the gastric varices, sclerosant was injected in a retrograde manner into the gastric varices from the balloon catheter. When retrograde venography showed that retention of contrast medium was insufficient because of the presence of collateral vessels, the collateral vessels were embolized using metallic coils before injection of the sclerosant. After infusion of the sclerosant, the balloon was kept inflated overnight, and the catheter was removed the next morning. The sclerosant was 5% ethanolamine oleate with iopamidol (EOI), which was prepared by mixing equal volumes of 10% ethanolamine oleate (Oldamin, Takeda Pharmaceutical) and iopamidol (Iopamiron; Schering). To prevent renal dysfunction caused by EOI-induced hemolysis, an IV drip infusion of 4,000 U of haptoglobin was given during injection of 5% EOI [16, 27].
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Percutaneous transhepatic sclerotherapy was performed in the following manner (Fig. 1B): Percutaneous transhepatic portography was performed using a 4-French catheter (Royal Flush Plus, Cook). Feeding and draining veins of the gastric varices were identified on portography, and a coaxial catheter was inserted into the feeding veins. Some metallic coils were placed in the feeding veins to reduce the blood flow in the gastric varices, and then sclerosant was injected in the antegrade direction into the gastric varices. After retention of the sclerosant in the gastric varices was confirmed, the catheter was removed. Five-percent EOI was used as the sclerosant, and 4,000 U of haptoglobin was administered by IV drip infusion during the injection of EOI [16, 27].
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Follow-Up
The medical records of the 104 patients with gastric varices were reviewed
retrospectively. Patients with no clinical visit during the most recent 6
months were contacted by telephone. The follow-up period was measured in days
from the date of TIPS placement or transcatheter sclerotherapy until the date
of death or the most recent clinical visit. The clinical examinations were
routinely performed in each group in the following manner.
In the TIPS group, portal and central venous pressures were measured before and after stenting. After TIPS placement, upper intestinal endoscopy was performed at 2 weeks, 3 and 6 months, and then every 6 months. The condition of the TIPS tract was examined using color Doppler sonography at 2 weeks and every 6 months. When the TIPS tract was narrowed or obstructed, the tract was recanalized using balloon angioplasty. Serum laboratory tests were performed to estimate changes in liver function at 3 and 6 months.
In the transcatheter sclerotherapy group, portal pressure was measured before and after sclerosing of gastric varices in patients who underwent puncture of the portal vein. After transcatheter sclerotherapy, blood flow in the gastric varices was evaluated at 2 weeks using color Doppler endoscopic sonography or contrast-enhanced CT. For patients in whom considerable blood flow remained, transcatheter sclerotherapy was repeated. Upper intestinal endoscopy and serum laboratory tests were performed as in the TIPS group. When endoscopy detected red spots on the esophageal varices, the varices were considered aggravated and were treated endoscopically.
Statistical Analysis
All results were expressed as mean ± standard deviation or frequency
(%). For comparison of patient characteristics between the TIPS and
transcatheter sclerotherapy groups, the Mann-Whitney U test was used
for quantitative measurements, and the chi-square test with Yates correction
was used for qualitative data. Changes in portal pressure and the
portosystemic pressure gradient were analyzed using the Student's paired
t test. The Kaplan-Meier method was used for the analyses of the
cumulative bleeding and survival rates, and the log-rank test was used for
comparison between the TIPS and transcatheter sclerotherapy groups.
Multivariate analysis using the Cox proportional hazards model was performed
for the prognostic factors related to bleeding of gastric varices and survival
after treatment. Changes in serum laboratory values were assessed by repeated
measures analysis of variance. When repeated measures analysis of variance
showed a significant difference, the Fisher least significant difference post
hoc test was used to compare the values before treatment in each group.
Statistical software (Statview version 5.0, SAS Institute) was used for
statistical analysis. Values for p of less than 0.05 were considered
significant for all tests.
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Techniques, Therapeutic Effects, and Complications
TIPS was performed in 27 patients and was technically successful in all
(100%). The mean portal pressures before and after stenting were 22.3 ±
8.4 mm Hg and 12.4 ± 4.0 mm Hg, respectively, a significant decrease
(n = 25, p < 0.01). The portosystemic pressure gradient
significantly decreased from 17.8 ± 7.7 mm Hg to 8.6 ± 3.3 mm Hg
(n = 25, p < 0.01). Gastric varices were resolved or
reduced in size in 15 patients (56%) after 2 weeks. However, no morphologic
change in gastric varices was endoscopically detected in 12 patients (44%),
who underwent additional coil embolizations for feeding veins via the TIPS
tract without the use of a sclerosant. Endoscopy after 3 months revealed that
gastric varices were completely resolved in six patients (22%) and were
smaller in 12 patients (44%); the effective rate of morphologic change was 66%
in the TIPS group. During the follow-up period, shunt dysfunction detected on
color Doppler sonography was observed in nine (33%) patients. The cumulative
rate of shunt dysfunction was 23% at 6 months and 36% at 1 year. To maintain
shunt patency, the nine patients with shunt dysfunction underwent shunt
recanalization with balloon angioplasty, which was successful in all (100%).
Hepatic encephalopathy occurred in five patients (19%), but the disorder was
controlled by medical treatment in all five.
Transcatheter sclerotherapy was performed in 77 patients. The B-RTO procedure was performed in 58 patients and was technically successful in 49 (84%). The percutaneous transhepatic sclerotherapy procedure was performed in 28 patients, including nine patients in whom the B-RTO procedure was unsuccessful. The percutaneous transhepatic sclerotherapy procedure was technically successful in all patients (100%). The mean portal pressures before and after transcatheter sclerotherapy were 22.8 ± 4.9 mm Hg and 26.1 ± 5.2 mm Hg, respectively, a significant increase (n = 28, p < 0.01). The amount of 5% EOI used for transcatheter sclerotherapy was 20.8 ± 14.3 mL. In 73 patients (95%), gastric varices were entirely, or mostly, thrombosed 2 weeks after transcatheter sclerotherapy. However, considerable blood flow in gastric varices remained in four patients (5%), who underwent transcatheter sclerotherapy again. Endoscopy after 3 months revealed that gastric varices were completely resolved in 53 patients (69%) and were markedly smaller in 23 patients (30%); the effective rate of morphologic change was 99% in the transcatheter sclerotherapy group. A complication, hematuria caused by EOI-induced hemolysis, was detected in all patients (100%), but renal dysfunction did not occur. Ascites was detected in six patients (8%) and pleural effusion in one patient (1%). However, these complications were temporary. Worsening of esophageal varices occurred in 14 patients (18%) within 6 months after transcatheter sclerotherapy and was successfully treated endoscopically.
Bleeding
During the follow-up period, bleeding of gastric varices occurred in six
patients (22%) in the TIPS group and in one patient (1%) in the transcatheter
sclerotherapy group (p < 0.01). TIPS dysfunction was found in two
of the six patients when bleeding occurred. No evidence was seen of TIPS
dysfunction in the remaining four patients. The cumulative gastric variceal
bleeding rate was significantly higher in the TIPS group than in the
transcatheter sclerotherapy group; the probability at 1 year was 20% in the
TIPS group and 2% in the transcatheter sclerotherapy group (p <
0.01, Fig. 2A). With respect to
previous episodes of gastric variceal bleeding, five patients (28%) of 18
patients in the TIPS group and one (3%) of 36 patients in the transcatheter
sclerotherapy group had rebleeding of gastric varices (p < 0.05).
The cumulative gastric variceal rebleeding rate at 1 year was 24% in the TIPS
group and 4% in the transcatheter sclerotherapy group (p < 0.01).
On multivariate analysis using the Cox proportional hazards model, the
treatment method alone was a significant prognostic factor of gastric variceal
bleeding after treatment (p < 0.05,
Table 2). Esophageal variceal
bleeding was observed in two patients (7%) in the TIPS group and in three
patients (4%) in the transcatheter sclerotherapy group. No significant
difference was seen in the cumulative rate of esophageal variceal bleeding
between the TIPS and transcatheter sclerotherapy groups; the probability at 1
year was 4% in the TIPS group and 4% in the transcatheter sclerotherapy group
(not significant, Fig. 2B).
Overall, the probability of variceal bleeding at 1 year was 23% in the TIPS
group and 6% in the transcatheter sclerotherapy group (p < 0.01,
Fig. 2C).
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Liver Function
Serum laboratory values were measured in all patients before treatment, but
24 patients in the TIPS group and 64 patients in the transcatheter
sclerotherapy group were observed at 3 and 6 months after treatment. Changes
in bilirubin, albumin, prothrombin time, and ammonia levels were evaluated in
each group.
Changes in serum laboratory values of the TIPS group are shown in Table 3. In the TIPS group, bilirubin was increased at 3 and 6 months (p < 0.05), and prothrombin time was transiently decreased at 3 months (p < 0.05). Significant changes were not found in albumin and ammonia levels. Improvement in liver function was not shown in the TIPS group. In terms of the Child-Pugh classification, liver function did not improved in the TIPS group.
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Changes in serum laboratory values of the transcatheter sclerotherapy group are presented in Table 4. In the transcatheter sclerotherapy group, the albumin level was increased and the ammonia level was decreased at both 3 and 6 months (p < 0.05). A significant increase in prothrombin time was observed at 6 months (p < 0.05). Significant changes were not seen in the bilirubin level. Liver function improved slightly in the transcatheter sclerotherapy group. According to the Child-Pugh classification, liver function improved in Child-Pugh classes B and C as well as in class A in the transcatheter sclerotherapy group.
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Survival
The cumulative survival rates at 1, 3, and 5 years, respectively, were 81%,
64%, and 40% in the TIPS group and 96%, 83%, and 76% in the transcatheter
sclerotherapy group. Survival rate was significantly higher in the
transcatheter sclerotherapy group (p < 0.01,
Fig. 3A). During the follow-up
period, 14 patients in the TIPS group and eight patients in the transcatheter
sclerotherapy group died. In the TIPS group, 10 patients (37%) died as a
result of hepatic failure, compared with three patients (4%) in the
transcatheter sclerotherapy group (p < 0.01). Two patients (7%) of
the TIPS group and three patients (4%) of the transcatheter sclerotherapy
group died of variceal bleeding (not significant). Death from hepatocellular
carcinoma, which occurred after the treatment of gastric varices, was observed
in two patients (7%) in the TIPS group and two patients (3%) in the
transcatheter sclerotherapy group (not significant). On the basis of the Cox
proportional hazards model, the treatment method and the Child-Pugh
classification were significant prognostic factors related to survival
(p < 0.05, Table
2).
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With respect to these prognosis-determining factors, the survival rates for patients categorized in Child-Pugh class A were 86%, 71%, and 55% at 1, 3, and 5 years, respectively, in the TIPS group, and 100%, 96%, and 96% in the transcatheter sclerotherapy group. A significant difference was seen between the two groups (p < 0.01, Fig. 3B). For patients in Child-Pugh classes B and C, the combined survival rates were 75%, 56%, and 22% in the TIPS group and 89%, 52%, and 26% in the transcatheter sclerotherapy group. No significant difference was seen between the two groups (Fig. 3C).
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TopAbstractIntroductionMaterials and MethodsResultsDiscussionReferences |
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Our comparative study had five major findings. First, the form of gastric varices was resolved more frequently in the transcatheter sclerotherapy group than in the TIPS group. Second, the rate of gastric variceal bleeding after treatment was lower in the transcatheter sclerotherapy group. Third, the rate of esophageal variceal bleeding was similar in both groups. Fourth, liver function tended to improve in the transcatheter sclerotherapy group. Finally, the survival rate, especially for patients in Child-Pugh class A, was higher in the transcatheter sclerotherapy group than in the TIPS group.
TIPS is a decompression therapy to prevent variceal bleeding; it reduces the portal pressure gradient in most patients with portal hypertension [8–13]. However, the effectiveness measured by improvement of gastric varices has been reported to be 50–63% [11, 28], which is similar to our result. Watanabe et al. [29] reported that patients with gastric varices have a spontaneous extensive portosystemic shunt and a lower portal pressure gradient. According to several reports, a decrease in portal pressure gradient by TIPS may be insufficient for resolving the form of gastric varices [11, 30, 31]. On the other hand, transcatheter sclerotherapy is a treatment aimed at thrombus formation in gastric varices. The thrombosed gastric varices have been reported to decrease and disappear in most patients [14–20, 22]. Our results are consistent with these reports. For resolving the form of gastric varices, TIPS may be less effective than transcatheter sclerotherapy.
Variceal bleeding rarely occurs if the portosystemic pressure gradient is less than 12 mm Hg [32], and this cutoff value is accepted as a clinical goal of TIPS. However, Tripathi et al. [33] recently reported that gastric variceal bleeding occurs more frequently in patients whose portosystemic pressure gradients are less than 12 mm Hg. TIPS may be inappropriate for the prevention of gastric variceal bleeding. Moreover, our results showed that the rate of gastric variceal bleeding was higher in the TIPS group than in the transcatheter sclerotherapy group. These results suggest that the disappearance or marked decrease in gastric varices is more important in preventing variceal bleeding than a decrease in the portosystemic pressure gradient. Indeed, variceal size and red spots were reported to be risk factors of gastric variceal bleeding [26].
In the transcatheter sclerotherapy group, esophageal varices were expected to become worse and bleed because of an elevated portal pressure. However, the rate of esophageal variceal bleeding was similar in the TIPS and transcatheter sclerotherapy groups. We propose that the worsening of esophageal varices after transcatheter sclerotherapy can be sufficiently controlled by endoscopic treatment. Ascites also is one of the complications caused by elevated portal pressure. If refractory ascites had appeared after transcatheter sclerotherapy, we would have performed additional TIPS. However, no patient required additional TIPS.
Reportedly, TIPS produces a decrease in the portal blood flow to the liver parenchyma, which may lead to reduction in liver function [34, 35]. Our results suggest that TIPS retains or slightly worsens liver function and that improvement in liver function is not seen. On the other hand, little has been reported on liver function after transcatheter sclerotherapy [15, 18]. In our study, transcatheter sclerotherapy was followed by improvement in liver function. An increase in portal blood flow, induced by the obstruction of large portosystemic shunts, may contribute to the improvement in liver function after transcatheter sclerotherapy.
Survival was significantly higher in the transcatheter sclerotherapy group. The 5-year cumulative survival rate for patients with gastric varices has been reported to be 51% after TIPS [33] and 61–69% after transcatheter sclerotherapy [18, 19]. Our results agree with these reports. Regarding the causes of death, hepatic failure was slightly more frequent in the TIPS group than in the transcatheter sclerotherapy group, suggesting that changes in liver function after treatment affect survival. According to the multivariate analysis, the treatment method and the Child-Pugh classification were significant prognostic factors for survival. Among patients in Child-Pugh class A, survival was significantly higher in the transcatheter sclerotherapy group than in the TIPS group. In Child-Pugh classes B and C, no significant difference was seen between the TIPS and transcatheter sclerotherapy groups. Hence, we propose that transcatheter sclerotherapy should be chosen for patients in Child-Pugh class A. In Child-Pugh classes B and C, it is desirable to choose transcatheter sclerotherapy because of its influences on gastric variceal bleeding and liver function. Our results cannot be applied to patients in Child-Pugh class C, because in our study the number of patients in that class was very small. Although our comparative study suggests five interesting findings, it is a retrospective study and could have a potential source of bias in data collection. However, we reviewed the medical records of all patients with gastric varices who were treated by TIPS or transcatheter sclerotherapy between March 1993 and June 2002, and no significant difference was seen in the clinical characteristics of the patients between the TIPS and transcatheter sclerotherapy groups. In addition, multivariate analysis showed the treatment method was a significant prognostic factor of gastric variceal bleeding and survival, and liver function tended to improve in the transcatheter sclerotherapy group. We believe that the results of this retrospective study are clinically valuable.
In conclusion, although TIPS is a useful treatment for portal hypertension, in patients with gastric varices transcatheter sclerotherapy may provide better control of variceal bleeding than TIPS does. Moreover, transcatheter sclerotherapy may be more useful than TIPS because of its influences on liver function, and transcatheter sclerotherapy may contribute to a higher survival rate than TIPS in patients with Child-Pugh class A. However, our study was retrospective, and further investigation with a prospective randomized study is necessary.
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