Surgical Endoscopy

Surg Endosc (1991) 5:28-30

© Springer-Verlag 1991

Endoscopic injection sclerotherapy in non-variceal upper gastrointestinal bleeding A comparative study of polidocanol and thrombin Giorgio Benedetti, Renato Sablich, and Teresa Lacchin Gastrointestinal Unit, Department of Surgery II, General Hospital, 1-33170 Pordenone, Italy

Summary. To date several agents have been used to achieve haemostasis in patients with non-variceal upper gastrointestinal bleeding using endoscopic sclerotherapy techniques. Polidocanol has been widely used but local complications have been reported after treatment. W e have c o m p a r e d the efficacy and safety o f thrombin and polidocanol in 82 consecutive patients with ongoing or recent bleeding f r o m duodenal, gastric, or anastomotic ulcers. Primary control of haemostasis f r o m spurting vessels was achieved in 90% of cases using polidocanol and in 86.6% using thrombin. Definitive haemostasis was obtained in 80% o f patients in both groups. W h e n a non-bleeding vessel was visible, injection of polidocanol or thrombin effectively prevented rebleeding in 90.9% and 85.7% of cases, respectively. W h e n a non-bleeding sentinel clot was present, injection o f polidocanol or thrombin provided definitive haemostasis in 100% and 92.8% o f cases, respectively. No statistically significant difference was evident between the two agents. In the polidocanol group, one local haemorrhagic complication was noted. N o general or local complications were recorded in the thrombin group.

Key words: Gastrointestinal bleeding - E n d o s c o p y Injection sclerotherapy

Endoscopic sclerotherapy using various different agents has b e c o m e an effective method of controlling active nonvariceal bleeding and preventing rebleeding when there is endoscopic evidence of a risk o f further haemorrhage (e. g. visible vessel or "sentinel clot") [ 1 , 3 - 1 2 ] . In Europe, polidocanol is the most widely used agent, but ulcers at the site of injection have been observed [12]. In a preliminary study, encouraging results with a low complication rate have been reported after injection of a solution o f bovine thrombin [3]. The aim o f this study was to compare the

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efficacy and safety of polidocanol and thrombin in the treatment o f bleeding peptic ulcers.

Patients and methods Patients with bleeding peptic ulcers diagnosed by endoscopy within 12 h of hospital admission were evaluated. Among these, the following subgroups were found to be unsuitable for the procedure and were excluded: (1) patients with giant ulcers covered by large fixed clots obscuring the haemorrhagic site; (2) patients with firm, sclerotic ulcers, impenetrable to the needle; and (3) patients with very deep ulcers suggesting an impending perforation. Overall, 82 consecutive patients met the above criteria and were admitted to the study. Endoscopy was carried out using Olympus GIF XQ10 and 1T instruments after pharyngeal anaesthesia and intravenous sedation. During the endoscopy, injection therapy was performed using a conventional sclerotherapy needle (23 G, 4-mm tip, Microvasive). There were 28 consecutive patients (male/female: 17/11; mean age, 63.2 years) treated with 1% polidocanol (Aethoxysklerol, Kreussler) injected around the lesion and into the bleeding site, in 1- 2 ml fractions, up to a maximum of 20 ml/lesion. A further group of 54 consecutive patients (male/female: 38/16; mean age, 61.2 years) were treated with 100 IU thrombin (Topostasin 3000, Roche) in 3 ml saline, up to a maximum of 25 ml. Thrombin dissolution in saline did not take more than 30 s. In this study, we have used the criteria set out by Forrest et al. [2] to describe the endoscopic appearances. In addition, the FII group has been further divided into the FIIa subgroup (non-bleeding, visible vessel) and the FIIb subgroup (non-bleeding, sentinel clot) according to Heldwein et al. [5]. Gentle suction and endoscopic washing was used before classifying the patient as described above. After sclerotherapy, patients were commenced on ranitidine 300 mg/nocte. Endoscopy was repeated if haematemesis and/or melena recurred; if the haematocrit remained low; or if there was a sudden fall in blood pressure. In all patients, endoscopy was repeated after 4 weeks. Statistical analysis was performed by the Z2 test.

Results The lesion site, bleeding classification, and treatment outc o m e are summarized in Tables 1 and 2. In the polidocanol group, active bleeding (FIa) was initially arrested in 9 out o f 10 cases (90%). In 1 patient with cirrhosis and liver cancer, injection therapy failed to control a spurting vessel within a gastric ulcer. The patient died soon after endoscopy f r o m haemorrhagic shock. T w o patients had recurrent

29 Table 1. Site and classification of haemorrhage according to Heldwein et al. [5]. s, Surgery; d, death

Thrombin

Polidocanol

Lesion

Duodenal ulcer

FIa Fib FIIa FIIb

6 (2s) 2 15 (is) 9

Total

32

FIa Fib FIIa FIIb Total

Gastric ulcer 8 (ld) 2 5 (ls) 5 (ls) 20

6 (ls) 7 4 17

4 (ld) 1 3 (1s) 2 10

Anastomotic ulcer

Total

1 1 (ls)

15 4 21 14

2

54

1 -

10 1 11 6

1

28

bleeding within 48 h. Definitive haemostasis was only achieved after surgery in 1 patient. The other had a mild self-limited rebleed from small ulcers which developed at the site of injection of 7 ml sclerosant. Thus, in the FIa subgroup, polidocanol provided definitive haemostasis in 8 out of 10 patients (80%). In the FIIa subgroup, 2 out of 11 patients rebled: the haemorrhage was definitively controlled by a second injection in 1 patient, but the other had to be operated on for massive bleeding. Thus, in the FIIa subgroup polidocanol provided definitive haemostasis in 90.9% of patients. Among 6 patients with sentinel clot (FIIb subgroup) treated with polidocanol, 1 rebled and was controlled by a second injection. Overall, definitive haemostasis was achieved in 89.2% of patients by polidocanol injection. In the thrombin group, FIa bleeding was initially arrested in 13 out of 15 cases. However, 2 patients rebled within 24 h. One of them, with disseminated cancer, died from haemorrhagic shock. The other was successfully treated by surgery. Among the 13 patients in whom bleeding had been initially arrested by thrombin injection, 3 rebled. Two were managed by a second endoscopic injection; the third failed to respond and required surgery. Thus, in the FIa subgroup thrombin provided definitive haemostasis in 12 out of 15 patients (80%). Among the 21 patients in the FIIa subgroup (non-bleeding, visible ves-

Table 2. Results of therapy. )~2 = n Polidocanol

Thrombin

0,8;

sel), 4 rebled. Only 1 patient was treated endoscopically; the other 3 patients required emergency surgery. Thus, endoscopic treatment was definitive in 18 out of 21 cases (85.7%). In the FIIb subgroup (non-bleeding, sentinel clot), 14 patients were treated by endoscopy. One rebled and was definitively controlled by surgery. Thus injection sclerotherapy using thrombin was effective in 92.8% of cases in the FIIb subgroup. Overall, definitive haemostasis was achieved in 87.0% by thrombin injection.

Discussion Endoscopic injection sclerotherapy is currently the least expensive and is a widely available technique which can be used to obtain haemostasis in patients with upper gastrointestinal non-variceal bleeding. A high success rate ( 7 0 100%) has been reported using various different agents [10], but comparative studies are lacking. Polidocanol is the most widely used sclerosant in Europe, either alone or in combination with diluted adrenalin. Local necrotizing complications may occur and may be responsible for late rebleeding and, rarely, perforation (1%) [3]. Relative inexperience of the operator and over-"generous" injection (more than 20 ml polidocanol) are reported as the possible causes of these complications [12]. In contrast, thrombin has been used infrequently in sclerotherapy although, from preliminary experience, it seems devoid of complications and is as effective as polidocanol [3]. In this series, the efficacy of sclerotherapy both in stopping active bleeding and in preventing rebleeding was high and appeared independent of the sclerosing agent. Overall, the rate of definitive haemostasis for FI and FII lesions was very similar for polidocanol and thrombin (Z 2 = 0.03; P = NS). Unlike the results of Heldwein et al. [5] our data suggest that the risk of rebleeding after sclerotherapy is independent of the pretreatment classification either as an FIIa or FIIb lesion. The mortality was highest in patients with gastric ulcer and pulsatile bleeding. Also, the highest failure rate occurred in patients with malignancy, irrespectively of the site of the lesion and bleeding classification. The coexistence of severely ill patients with a poor surgical prognosis could account for the mortality (2.4%) recorded in this and other comparable series [8, 11]. In 1 patient treated with polidocanol a minor haemorrhage occurred from injection site ulcers despite the small volume of

P = NS Temporary haemostasis

Recurrence

Surgery

Death

Definitive haemostasis

% 80 100

FIa Fib

10 1

9 1

2 -

1 -

1 -

8 1

FIIa FIIb

l1 6

i1 -

2 1

1

0 -

10 6

90.9 100

FIa Fib

15 4

13 4

3 -

2 -

1 -

12 4

80 100

FIIa FIIb

21 14

-

4 1

3 1

-

18 13

85.7 92.8

30 sclerosant injected. I n contrast, we did not observe any local or general c o m p l i c a t i o n in the t h r o m b i n group. However, it is likely that larger series are needed to definitively assess the safety profile of this agent.

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