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A prospective randomized trial of heater probe thermocoagulation versus injection therapy in peptic ulcer hemorrhage
0016-5107/96/4302-011755.00 + 0 GASTROINTESTINAL ENDOSCOPY Copyright 9 1996 by the American Society for Gastrointestinal Endoscopy
A prospective randomized trial of heater probe thermocoagulation versus injection therapy in peptic ulcer hemorrhage J. Llach, MD, J.M. Bordas, MD, J.M. Salmerbn, MD, J. Pands, MD, J.C. Garcia-Pagdn, MD F. Feu, MD, M. Navasa, MD, F. Mondelo, MD, J.M. Pique, MD A. Mas, MD, J. Terds, MD, J. Rodds, MD
Background: A prospective, randomized study was performed to compare the hemostatic effect of injection therapy and heater probe thermocoagulation in the treatment of peptic ulcer bleeding. Methods: This study includes 104 patients with upper gastrointestinal bleeding in whom endoscopy revealed a gastric or duodenal ulcer with nonbleeding or bleeding vessel (n = 66), oozing hemorrhage (n = 21), or adherent red clot (n = 17). Patients with other stigmata or clean ulcers were excluded. Patients were randomly assigned during endoscopy to receive injection therapy (adrenaline and polidocanol) (n = 51) or heater probe thermocoagulation (10F probe, at setting of 30 J (n = 53). Therapy was considered successful if there was no further hemorrhage or only minor rebleeding that was controlled with a second endoscopic procedure. Patients with major rebleeding or failure of retreatment underwent emergency surgery. Results: There were no significant differences in effectiveness between injection therapy and thermocoagulation in any of the assessed parameters: the percentage of patients with major recurrent hemorrhage (4% vs 6%) or minor rebleeding (16% vs 17%), need for emergency surgery (two patients from each group), transfusion requirement (0.45 • 0.9 units vs 0.51 • 1.1 units), the mean number of hospitalization days (7.1 • 4.2 vs 6.9 • 4.9), and mortality (one patient from each group died). Conclusion: Injection therapy and heater probe have similar efficacies in the treatment of bleeding peptic ulcers. (Gastrointest Endosc 1996;43:117-20.) Hemostasis using endoscopic methods is a major advance in the management of patients with bleeding ulcers. There are two groups of modalities used in the endoscopic treatment of bleeding peptic ulcers: thermal devices including bipolar probes, laser, and heater probe; and injection therapy. Endoscopically applied contact thermal probes, mainly bipolar or heater probes, allow heat and pressure to be applied simultaneously to the bleeding lesion. These methods have been shown to be clinically useful.l-5 Laser photocoagulation is associated with risks of perforation, optical Received March 6, 1995. For revision March 29, 1995. Accepted June 29, 1995. From the Departments of Gastroenterology and Hepatology, Hospital Clinic i Provincial, Barcelona, Spain. Reprint requests: J.M. Bordas, MD, Endoscopy, Hospital Clinic i Provincial, ViUarroel 170, 08036 Barcelona, Spain. 37/1/67493
VOLUME 43, NO. 2, PART 1, 1996
hazard, high cost, and imperfect hemostatic effect. Multipolar electrocoagulation and heater probe thermocoagulation have been reported to have excellent results. 6-13They are less expensive and more portable than the laser and are more widely available. A number of controlled studies of injection therapy for bleeding ulcers have uniformly shown that it is a beneficial therapy.3, 14-18 The efficacy and safety of heater probe thermocoagulation remains somewhat controversial. 11,12,19 This report aims to evaluate thermocoagulation in comparison to endoscopic injection therapy in the treatment of bleeding peptic ulcers in humans. PATIENTS AND METHODS All patients admitted with upper gastrointestinal hemorrhage and those who had upper gastrointestinal bleeding after admission for unrelated disorders GASTROINTESTINAL ENDOSCOPY
117
Table 1. Data of patients at the start of the trial Injection therapy No. of patients 51 Mean age (y) 59.1 _+ 15.2 Sex (M/F) 40/11 Cardiorespiratory diseases 5 Liver cirrhosis 2 Previous ulcer symptoms 25 Previous upper bleeding 12 Systolic blood pressure 115 _+ 25 (mm Hg) Mean hemoglobin (grrddL) 9.1 +_ 2.5 Blood transfused before randomization (units) 1.7 _+ 1.4 Location of ulcer Gastric 16 Duodenal 35 Endoscopic data of recent hemorrhage Vessel* 32 Oozing hemorrhage 10 Adherent red clot 9
Heater probe 53 60.5 -+ 16.3 41/12 6 2 26 14 117 _ 19 9.2 _+ 2.4 1.6 _+ 1.3 17 36 34 11 8
*Includes bleeding and nonbleeding vessels.
were considered for inclusion in the trial. Endoscopic evaluation was performed within 6 hours of admission, or within 6 hours of hemorrhage detection in patients who were already hospitalized. Patients were included in the study if endoscopy showed a gastric or duodenal ulcer with a bleeding or nonbleeding visible vessel, oozing hemorrhage, or an adherent red clot. Ulcers with oozing were considered to be actively bleeding only if oozing was persistent and unrelated to endoscopic trauma. In some cases oozing was associated with stigmata such as clots. Patients showing flat-pigmented spots at the ulcer base were excluded. According to the nature of the endoscopic data, patients were stratified prospectively into three different groups: (1) bleeding or nonbleeding visible vessel, (2) oozing hemorrhage, and (3) red clot adherent to the ulcer base. Stratification was designed to ensure uniformity of patients in the therapy arms and to study the outcome for each level of stratification in addition to the groups as a whole. All patients undergoing emergency endoscopy for bleeding gave informed consent for possible endoscopic hemostasis. The protocol was approved by the hospital Ethics Committee. Randomization into injection or heater probe treatment was carried out at the time of endoscopy. Three sets of sealed numbered envelopes containing the treatment option, which was determined by a computer generated number list, were used. For endoscopic sclerosis, the base of the ulcer was first injected with 3 to 10 ml of adrenaline (1/10,000), using injections of 0.5 to 1 ml. If a visible vessel was seen, adrenaline was injected around and into its lumen. Then 6 to 12 ml of 118
GASTROINTESTINAL ENDOSCOPY
Table 2. Comparison of results in heater probe thermocoagulation and injection therapy in patients with bleeding peptic ulcers
Major recurrent hemorrhage Minor recurrent hemorrhage Emergency surgery required Blood transfusion aider entry into trial (units) Median hospital stay (d) Perforation Deaths Deaths due to bleeding
Injection therapy (n = 51)
Heater probe (n = 53)
2 (4%) 3 (16%) 2 (4%) 0.45 _ 0.9
3 (6%) 9 (17%) 2 (4%) 0.51 _+ 1.1
7.1 _ 4.2 0 1 (2%) 0 (0%)
6.9 _+ 4.9 0 1 (2%) 1 (2%)
polidocanol (1/100) was injected in the same way. If bleeding persisted, adrenaline and polidocanol were again injected without exceeding the total dose of 10 ml of adrenaline and 18 ml of polidocanol. For thermocoagulation, the Olympus Heat Probe Unit, with the 10F probe, was used at a setting of 30 J (Olympus Corp., Hamburg, Germany). The probe was positioned directly on the bleeding point, and firm tamponade was applied with the probe before its activation. The top of the probe was applied circumferentially around the bleeding site for four to eight pulses. The bleeding site was observed for 5 minutes. At the end of this time, the bleeding site was challenged with maximal water irrigation for 10 seconds. If any further hemorrhage occurred, the above procedure was repeated until no more bleeding was seen. After endoscopy the patients were returned to the ward to continue under the care of the referring physician, who was unaware of the treatment that had been applied. All patients were given histamine-2 receptor antagonists (ranitidine, 50 mg intravenously every 6 hours). Blood pressure and pulse were monitored hourly. The gastric contents were monitored via a nasogastric tube. Major recurrence or persistent bleeding was defined as the presence ofhematemesis, blood-tinged gastric aspirates, and/or melena, with a sudden decrease (more than 30 mm Hg) of systolic blood pressure or a requirement of 4 or more units of blood within 48 hours to maintain hemoglobin levels above 10 gm/100 mL after the patient had been stabilized. Minor rebleeding was defined as the presence of red blood in the gastric aspirate or melena associated with a fall in hemoglobin concentration, without significant changes in blood pressure, and transfusion requirements of less than 4 units of blood within 48 hours after stabilization. A second endoscopy was carried out in patients with minor rebleeding or routinely 24 hours after the procedure in all patients without evidence of bleeding. If active bleeding was seen, retreatment using the same method was perVOLUME 43, NO. 2, PART 1, 1996
Table 3. Course of bleeding according to the endoscopic characteristics of the ulcers Bleeding vessel*
No. of patients Major rebleeding Minor rebleeding Emergency surgery Deaths
Nonbleeding visible vessel
Oozing hemorrhage
Adherent red clot
IT
HP
IT
HP
IT
HP
IT
HP
13 0 2 0 0
14 0 2 0 0
19 1 2 1 0
20 1 3 1 0
10 1 2 1 0
11 1 2 0 1
9 0 2 0 1
8 1 2 1 0
IT, Injection therapy; liP, heater probe thermocoagulation. *Spurting arterial hemorrhage was present in 18 patients, 9 in each therapeutic group. The remaining 9 patients had a nonpulsatile bleeding.
formed. Therapy was considered successful if there was no further hemorrhage or only minor rebleeding that was controlled with a second endoscopic procedure up to the time of discharge, and a failure if major rebleeding or recurrence of minor rebleeding occurred during hospitalization. Patients with major rebleeding or failure of retreatment underwent emergency surgery. The significance of differences was assessed by Chi-squared analysis with Yates correction for the qualitative variables and by the Mann-Whitney test for continuous variables. Results are presented as mean +__SDM.
RESULTS From J a n u a r y 1993 to March 1994, 1214 patients underwent emergency endoscopy for acute upper gastrointestinal hemorrhage. Ulcers were considered the source of bleeding in 489 patients. According to predefined endoscopic criteria, 104 patients entered into the study. Three patients who had active bleeding at the time of endoscopy were excluded because the bleeding lesion could not be seen. No patient refused to enter the trial. The features of the patients randomized into the injection therapy and the heater probe groups at entry into the trial are summarized in Table 1. Both groups were comparable in clinical characteristics, location of ulcer, and severity of bleeding. Initial hemostasis considered at the end of the endoscopic therapy was obtained in all cases. Two patients in the injection therapy group and three patients in the heater probe group had criteria of major recurrent hemorrhage. Two patients in the sclerosis group and two of the three patients of the thermocoagulation group with major rebleeding underwent emergency surgery. One patient from the heater probe group died suddenly as a consequence of bleeding before the surgical procedure could be performed. The proportion of patients who had minor rebleeding and required a second application of the endoscopic treatment to achieve definitive hemostasis was similar in VOLUME 43, NO. 2, PART 1, 1996
the injection therapy group (16%) and in the heater probe group (17%). In all of these cases, minor rebleeding was identified before the second endoscopic procedure, and in all cases retreatment achieved definitive hemostasis. Transfusion requirements after inclusion in the study as well as the duration of hospital stay were similar in the two treatment groups (Table 2). Two patients included in the study, one from each group, died during the hospitalization. In the patient from the injection therapy group, death was not related to the hemorrhage and was a consequence of underlying disease. In the heater probe group, one patient died as a consequence of sudden massive hemorrhage. When patients were evaluated according to the endoscopic characteristics of the bleeding ulcer (i.e., bleeding vessel, nonbleeding vessel, oozing hemorrhage, or clot), no significant differences in rebleeding, emergency surgery, and transfusion requirements between the two treatment modalities were observed (Table 3). There were no perforations in either group. None of the four patients that underwent emergency surgery had evidence of rebleeding after surgery. The duration of the entire endoscopic procedure was similar in the injection therapy group (14.1 __+4.1 min) and in the heater probe group (13.5 - 3.9 min). The mean volume of adrenaline and polidocanol injected per session was 6.5 _+ 3.1 mL, (range 4 to 10) and 9.4 _+ 4.2 mL (range 4 to 12), respectively. In the initial treatment, the mean number of pulses per session was 7.2 (range 5 to 8). Patients with retreatment received an additional mean of 5.7 pulses (range 4 to 7).
DISCUSSION In the present study the effectiveness of heater probe thermocoagulation was similar to that of injection therapy in controlling acute hemorrhage from peptic ulcers with a high risk of bleeding according to endoscopic criteria. The effectiveness of injection therGASTROINTESTINAL ENDOSCOPY
119
apy and heater probe thermocoagulation observed in our group of patients is similar to that observed in other published controlled studies. In reports comparing different procedures, endoscopic sclerosis has been shown to have a similar efficacy to that of laser, microwave coagulation, and bipolar electrocoagulation in the treatment of bleeding ulcers. 6, 9, 18, 19 However, little and controversial information is available on the effect of heater probe thermocoagulation in this condition.S, 11, 12, 19 It has been suggested that the heater probe may be more effective in spurters because the distal tip of the probe can be applied for thermocoagulation at the bleeding site. Moreover, tangential application of the heater probe is more feasible than injection with the sclerosis catheter over the lesser curvature and posterior wall of the stomach and superior wall of the duodenal bulb. Although the success rate in the heater probe group in our series was similar to that in the sclerosis group (with regard to arresting bleeding over the posterior wall of the stomach or duodenal bulb) as well as in patients with active hemorrhage, the case number in both groups may be too small to be conclusive. The efficacy of repeated endoscopic therapy for rebleeding ulcers is very high, as already reported in previous trials.15, is An important finding of this study is the very high effectiveness of repeated endoscopic or thermocoagulation therapy for minor rebleeding, inasmuch as no patients with minor rebleeding needed surgical therapy. In the sclerosis group, 16% of the patients had minor rebleeding aider the first sclerosis and required a second session of injection therapy to achieve permanent hemostasis. The proportion was similar in the heater probe group, with 17% of the patients requiring a second thermocoagulation procedure to achieve permanent hemostasis. In our series, all patients with minor recurrent hemorrhage needing a second therapeutic procedure had clinical or laboratory data suggesting bleeding. In all these cases endoscopic reevaluation confirmed the presence of hemorrhage. In this trial, repeated endoscopy was routinely carried out during the first 24 hours to identL~ypatients with rebleeding to repeat the treatment. Only patients with clinical or laboratory data indicative of rebleeding had endoscopic criteria for retreatment and no patients without endoscopic criteria for retreatment had clinical or laboratory evidence of rebleeding. These data are in accordance with the results from a retrospective study of our group suggesting that systematic endoscopic review is not necessary in patients with hemorrhage from gastroduodenal ulcers which have been treated with endoscopic therapy. 2~ Injection therapy and heater probe thermocoagulation have the advantage of safety and portability and are relatively easy to purchase and maintain. We conclude that heater probe thermocoagulation is as effec120 GASTROINTESTINAL ENDOSCOPY
tive and safe as injection therapy in arresting peptic ulcer hemorrhage. REFERENCES 1. Laine L. Multipolar electrocoagulation in the treatment of active upper gastrointestinal tract hemorrhage. A prospective controlled trial. N Engl J Med 1987;316:1613-7. 2. LaineL. Multipolar electrocoagulation in the treatment ofpeptic ulcers with nonbleeding visible vessels: a prospective controlled trial. Ann Intern Med 1989;110:510-4. 3. Rutgeerts P, Vantrappen G, Broeckaert L, Coremans G, Janssens J, Hiele M. Comparison of endoscopic polidocanol injection and YAG laser therapy for bleeding peptic ulcers. Lancet 1989; 1:1164-7. 4. Rutgeerts P, Vantrappen G, Van Hootegem Ph, et al. Neodynium-YAG laser photecoagulation versus multipolar electrocoagulation for the treatment of severely bleeding ulcers: a randomized comparison. Gastrointest Endosc 1987;33:199-202. 5. Goff JS. Bipolar electrocoagulation versus Nd-YAG laser photocoagulation for upper gastrointestinal bleeding lesions. Dig Dis Sci 1986;31:906-10. 6. Laine L. Multipolar electrocoagulationversus injection therapy in the treatment of bleeding peptic ulcers. A prospective randomized trial. Gastroenterology 1990;99:1303-6. 7. Johnston JH, Sones JQ, Long BW, Posey EL. Comparison of heater probe and YAG laser in endoscopic treatment of major bleeding from peptic ulcers. Gastrointest Endosc 1985;31:17580. 8. Jaramillo JL, Carmona C, Galvez C, de la Mata M, Mifio G. Efficacy of the heater probe in peptic ulcer with a non-bleeding visible vessel. A controlled, randomised study. Gut 1993;34: 1502-6. 9. Choudari CP, Rajgopal C, Palmer KR. Comparison of endoscopic injection therapy versus the heater probe in major peptic ulcer hemorrhage. Gut 1992;33:1159-61. 10. Fullerton GM, Birnie GC, MacDonald A, Murray WR. Controlled trial of heater probe treatment in bleeding peptic ulcers. Br J Surg 1989;76:541-4. 11. Lin HJ, Tsai YT, Lee SD, et al. A prospectively randomized trial of heat probe thermocoagulation versus pure alcohol injection in nonvariceal peptic ulcer hemorrhage. Am J Gastroenterol 1988;83:283-6. 12. Lin HJ, Lee FY, Kang WM, Tsai YT, Lee SD, Lee CH. Heat probe thermocoagulation and pure alcohol injection in massive peptic ulcer haemorrhage: a prospective, randomized controlled trial. Gut 1990;31:753-7. 13. Lin HJ, Lee FY, Kang WM, Tsai YT, Lee SD, Lee CH. A controlled study of therapeutic endoscopy for peptic ulcer with non-bleedingvisible vessel. Gastrointest Endosc 1990;36:241-6. 14. Pascu O, Dr~ghici A, Acalovachi I. The effect of endoscopic haemostasis with alcohol on the mortality rate of non variceal upper GI hemorrhage. A randomized prospective study. Endoscopy 1989;21:53-5. 15. Pan~s J, Viver J, Forn~ M, Garcia-Olivares E, Marco C, Garau J. Controlled trial of endoscopic sclerosis in bleeding peptic ulcers. Lancet 1987;2:1292-4. 16. Balanz5 J, Sainz S, Such J, et al. Endoscopic hemostasis by local injection of epinephrine and polidocanol in bleeding ulcer. A prospective randomized trial. Endoscopy 1988;20:289-91. 17. Chung SCS, Leung JWC, Steele RJC, Croi~s TJ, Li AKC. Endoscopic injection of adrenaline for actively bleeding ulcers: a randomized trial. Br Med J 1988;296:1631-3. 18. Pan~s J, Viver J, Forn~ M. Randomized comparison of endoscopic microwave coagulation and endoscopic sclerosis in the treatment of bleeding peptic ulcers. Gastrointest Endosc 1991; 37:611-6. 19. Chung SCS, Leung JWC, Sung JY, Lo KK, Li AKC. Injection or heat probe for bleeding ulcer. Gastroenterology 1991;100: 33-7. 20. Elizalde JI, LLach J, Bordas JM, et al. The value of endoscopic control following sclerotherapy of gastroduodenal peptic lesion. Gastroenterol Hepatel 1994;17:21-3.
VOLUME 43, NO. 2, PART 1, 1996
A prospective randomized trial of heater probe thermocoagulation versus injection therapy in peptic ulcer hemorrhage J. Llach, MD, J.M. Bordas, MD, J.M. Salmerbn, MD, J. Pands, MD, J.C. Garcia-Pagdn, MD F. Feu, MD, M. Navasa, MD, F. Mondelo, MD, J.M. Pique, MD A. Mas, MD, J. Terds, MD, J. Rodds, MD
Background: A prospective, randomized study was performed to compare the hemostatic effect of injection therapy and heater probe thermocoagulation in the treatment of peptic ulcer bleeding. Methods: This study includes 104 patients with upper gastrointestinal bleeding in whom endoscopy revealed a gastric or duodenal ulcer with nonbleeding or bleeding vessel (n = 66), oozing hemorrhage (n = 21), or adherent red clot (n = 17). Patients with other stigmata or clean ulcers were excluded. Patients were randomly assigned during endoscopy to receive injection therapy (adrenaline and polidocanol) (n = 51) or heater probe thermocoagulation (10F probe, at setting of 30 J (n = 53). Therapy was considered successful if there was no further hemorrhage or only minor rebleeding that was controlled with a second endoscopic procedure. Patients with major rebleeding or failure of retreatment underwent emergency surgery. Results: There were no significant differences in effectiveness between injection therapy and thermocoagulation in any of the assessed parameters: the percentage of patients with major recurrent hemorrhage (4% vs 6%) or minor rebleeding (16% vs 17%), need for emergency surgery (two patients from each group), transfusion requirement (0.45 • 0.9 units vs 0.51 • 1.1 units), the mean number of hospitalization days (7.1 • 4.2 vs 6.9 • 4.9), and mortality (one patient from each group died). Conclusion: Injection therapy and heater probe have similar efficacies in the treatment of bleeding peptic ulcers. (Gastrointest Endosc 1996;43:117-20.) Hemostasis using endoscopic methods is a major advance in the management of patients with bleeding ulcers. There are two groups of modalities used in the endoscopic treatment of bleeding peptic ulcers: thermal devices including bipolar probes, laser, and heater probe; and injection therapy. Endoscopically applied contact thermal probes, mainly bipolar or heater probes, allow heat and pressure to be applied simultaneously to the bleeding lesion. These methods have been shown to be clinically useful.l-5 Laser photocoagulation is associated with risks of perforation, optical Received March 6, 1995. For revision March 29, 1995. Accepted June 29, 1995. From the Departments of Gastroenterology and Hepatology, Hospital Clinic i Provincial, Barcelona, Spain. Reprint requests: J.M. Bordas, MD, Endoscopy, Hospital Clinic i Provincial, ViUarroel 170, 08036 Barcelona, Spain. 37/1/67493
VOLUME 43, NO. 2, PART 1, 1996
hazard, high cost, and imperfect hemostatic effect. Multipolar electrocoagulation and heater probe thermocoagulation have been reported to have excellent results. 6-13They are less expensive and more portable than the laser and are more widely available. A number of controlled studies of injection therapy for bleeding ulcers have uniformly shown that it is a beneficial therapy.3, 14-18 The efficacy and safety of heater probe thermocoagulation remains somewhat controversial. 11,12,19 This report aims to evaluate thermocoagulation in comparison to endoscopic injection therapy in the treatment of bleeding peptic ulcers in humans. PATIENTS AND METHODS All patients admitted with upper gastrointestinal hemorrhage and those who had upper gastrointestinal bleeding after admission for unrelated disorders GASTROINTESTINAL ENDOSCOPY
117
Table 1. Data of patients at the start of the trial Injection therapy No. of patients 51 Mean age (y) 59.1 _+ 15.2 Sex (M/F) 40/11 Cardiorespiratory diseases 5 Liver cirrhosis 2 Previous ulcer symptoms 25 Previous upper bleeding 12 Systolic blood pressure 115 _+ 25 (mm Hg) Mean hemoglobin (grrddL) 9.1 +_ 2.5 Blood transfused before randomization (units) 1.7 _+ 1.4 Location of ulcer Gastric 16 Duodenal 35 Endoscopic data of recent hemorrhage Vessel* 32 Oozing hemorrhage 10 Adherent red clot 9
Heater probe 53 60.5 -+ 16.3 41/12 6 2 26 14 117 _ 19 9.2 _+ 2.4 1.6 _+ 1.3 17 36 34 11 8
*Includes bleeding and nonbleeding vessels.
were considered for inclusion in the trial. Endoscopic evaluation was performed within 6 hours of admission, or within 6 hours of hemorrhage detection in patients who were already hospitalized. Patients were included in the study if endoscopy showed a gastric or duodenal ulcer with a bleeding or nonbleeding visible vessel, oozing hemorrhage, or an adherent red clot. Ulcers with oozing were considered to be actively bleeding only if oozing was persistent and unrelated to endoscopic trauma. In some cases oozing was associated with stigmata such as clots. Patients showing flat-pigmented spots at the ulcer base were excluded. According to the nature of the endoscopic data, patients were stratified prospectively into three different groups: (1) bleeding or nonbleeding visible vessel, (2) oozing hemorrhage, and (3) red clot adherent to the ulcer base. Stratification was designed to ensure uniformity of patients in the therapy arms and to study the outcome for each level of stratification in addition to the groups as a whole. All patients undergoing emergency endoscopy for bleeding gave informed consent for possible endoscopic hemostasis. The protocol was approved by the hospital Ethics Committee. Randomization into injection or heater probe treatment was carried out at the time of endoscopy. Three sets of sealed numbered envelopes containing the treatment option, which was determined by a computer generated number list, were used. For endoscopic sclerosis, the base of the ulcer was first injected with 3 to 10 ml of adrenaline (1/10,000), using injections of 0.5 to 1 ml. If a visible vessel was seen, adrenaline was injected around and into its lumen. Then 6 to 12 ml of 118
GASTROINTESTINAL ENDOSCOPY
Table 2. Comparison of results in heater probe thermocoagulation and injection therapy in patients with bleeding peptic ulcers
Major recurrent hemorrhage Minor recurrent hemorrhage Emergency surgery required Blood transfusion aider entry into trial (units) Median hospital stay (d) Perforation Deaths Deaths due to bleeding
Injection therapy (n = 51)
Heater probe (n = 53)
2 (4%) 3 (16%) 2 (4%) 0.45 _ 0.9
3 (6%) 9 (17%) 2 (4%) 0.51 _+ 1.1
7.1 _ 4.2 0 1 (2%) 0 (0%)
6.9 _+ 4.9 0 1 (2%) 1 (2%)
polidocanol (1/100) was injected in the same way. If bleeding persisted, adrenaline and polidocanol were again injected without exceeding the total dose of 10 ml of adrenaline and 18 ml of polidocanol. For thermocoagulation, the Olympus Heat Probe Unit, with the 10F probe, was used at a setting of 30 J (Olympus Corp., Hamburg, Germany). The probe was positioned directly on the bleeding point, and firm tamponade was applied with the probe before its activation. The top of the probe was applied circumferentially around the bleeding site for four to eight pulses. The bleeding site was observed for 5 minutes. At the end of this time, the bleeding site was challenged with maximal water irrigation for 10 seconds. If any further hemorrhage occurred, the above procedure was repeated until no more bleeding was seen. After endoscopy the patients were returned to the ward to continue under the care of the referring physician, who was unaware of the treatment that had been applied. All patients were given histamine-2 receptor antagonists (ranitidine, 50 mg intravenously every 6 hours). Blood pressure and pulse were monitored hourly. The gastric contents were monitored via a nasogastric tube. Major recurrence or persistent bleeding was defined as the presence ofhematemesis, blood-tinged gastric aspirates, and/or melena, with a sudden decrease (more than 30 mm Hg) of systolic blood pressure or a requirement of 4 or more units of blood within 48 hours to maintain hemoglobin levels above 10 gm/100 mL after the patient had been stabilized. Minor rebleeding was defined as the presence of red blood in the gastric aspirate or melena associated with a fall in hemoglobin concentration, without significant changes in blood pressure, and transfusion requirements of less than 4 units of blood within 48 hours after stabilization. A second endoscopy was carried out in patients with minor rebleeding or routinely 24 hours after the procedure in all patients without evidence of bleeding. If active bleeding was seen, retreatment using the same method was perVOLUME 43, NO. 2, PART 1, 1996
Table 3. Course of bleeding according to the endoscopic characteristics of the ulcers Bleeding vessel*
No. of patients Major rebleeding Minor rebleeding Emergency surgery Deaths
Nonbleeding visible vessel
Oozing hemorrhage
Adherent red clot
IT
HP
IT
HP
IT
HP
IT
HP
13 0 2 0 0
14 0 2 0 0
19 1 2 1 0
20 1 3 1 0
10 1 2 1 0
11 1 2 0 1
9 0 2 0 1
8 1 2 1 0
IT, Injection therapy; liP, heater probe thermocoagulation. *Spurting arterial hemorrhage was present in 18 patients, 9 in each therapeutic group. The remaining 9 patients had a nonpulsatile bleeding.
formed. Therapy was considered successful if there was no further hemorrhage or only minor rebleeding that was controlled with a second endoscopic procedure up to the time of discharge, and a failure if major rebleeding or recurrence of minor rebleeding occurred during hospitalization. Patients with major rebleeding or failure of retreatment underwent emergency surgery. The significance of differences was assessed by Chi-squared analysis with Yates correction for the qualitative variables and by the Mann-Whitney test for continuous variables. Results are presented as mean +__SDM.
RESULTS From J a n u a r y 1993 to March 1994, 1214 patients underwent emergency endoscopy for acute upper gastrointestinal hemorrhage. Ulcers were considered the source of bleeding in 489 patients. According to predefined endoscopic criteria, 104 patients entered into the study. Three patients who had active bleeding at the time of endoscopy were excluded because the bleeding lesion could not be seen. No patient refused to enter the trial. The features of the patients randomized into the injection therapy and the heater probe groups at entry into the trial are summarized in Table 1. Both groups were comparable in clinical characteristics, location of ulcer, and severity of bleeding. Initial hemostasis considered at the end of the endoscopic therapy was obtained in all cases. Two patients in the injection therapy group and three patients in the heater probe group had criteria of major recurrent hemorrhage. Two patients in the sclerosis group and two of the three patients of the thermocoagulation group with major rebleeding underwent emergency surgery. One patient from the heater probe group died suddenly as a consequence of bleeding before the surgical procedure could be performed. The proportion of patients who had minor rebleeding and required a second application of the endoscopic treatment to achieve definitive hemostasis was similar in VOLUME 43, NO. 2, PART 1, 1996
the injection therapy group (16%) and in the heater probe group (17%). In all of these cases, minor rebleeding was identified before the second endoscopic procedure, and in all cases retreatment achieved definitive hemostasis. Transfusion requirements after inclusion in the study as well as the duration of hospital stay were similar in the two treatment groups (Table 2). Two patients included in the study, one from each group, died during the hospitalization. In the patient from the injection therapy group, death was not related to the hemorrhage and was a consequence of underlying disease. In the heater probe group, one patient died as a consequence of sudden massive hemorrhage. When patients were evaluated according to the endoscopic characteristics of the bleeding ulcer (i.e., bleeding vessel, nonbleeding vessel, oozing hemorrhage, or clot), no significant differences in rebleeding, emergency surgery, and transfusion requirements between the two treatment modalities were observed (Table 3). There were no perforations in either group. None of the four patients that underwent emergency surgery had evidence of rebleeding after surgery. The duration of the entire endoscopic procedure was similar in the injection therapy group (14.1 __+4.1 min) and in the heater probe group (13.5 - 3.9 min). The mean volume of adrenaline and polidocanol injected per session was 6.5 _+ 3.1 mL, (range 4 to 10) and 9.4 _+ 4.2 mL (range 4 to 12), respectively. In the initial treatment, the mean number of pulses per session was 7.2 (range 5 to 8). Patients with retreatment received an additional mean of 5.7 pulses (range 4 to 7).
DISCUSSION In the present study the effectiveness of heater probe thermocoagulation was similar to that of injection therapy in controlling acute hemorrhage from peptic ulcers with a high risk of bleeding according to endoscopic criteria. The effectiveness of injection therGASTROINTESTINAL ENDOSCOPY
119
apy and heater probe thermocoagulation observed in our group of patients is similar to that observed in other published controlled studies. In reports comparing different procedures, endoscopic sclerosis has been shown to have a similar efficacy to that of laser, microwave coagulation, and bipolar electrocoagulation in the treatment of bleeding ulcers. 6, 9, 18, 19 However, little and controversial information is available on the effect of heater probe thermocoagulation in this condition.S, 11, 12, 19 It has been suggested that the heater probe may be more effective in spurters because the distal tip of the probe can be applied for thermocoagulation at the bleeding site. Moreover, tangential application of the heater probe is more feasible than injection with the sclerosis catheter over the lesser curvature and posterior wall of the stomach and superior wall of the duodenal bulb. Although the success rate in the heater probe group in our series was similar to that in the sclerosis group (with regard to arresting bleeding over the posterior wall of the stomach or duodenal bulb) as well as in patients with active hemorrhage, the case number in both groups may be too small to be conclusive. The efficacy of repeated endoscopic therapy for rebleeding ulcers is very high, as already reported in previous trials.15, is An important finding of this study is the very high effectiveness of repeated endoscopic or thermocoagulation therapy for minor rebleeding, inasmuch as no patients with minor rebleeding needed surgical therapy. In the sclerosis group, 16% of the patients had minor rebleeding aider the first sclerosis and required a second session of injection therapy to achieve permanent hemostasis. The proportion was similar in the heater probe group, with 17% of the patients requiring a second thermocoagulation procedure to achieve permanent hemostasis. In our series, all patients with minor recurrent hemorrhage needing a second therapeutic procedure had clinical or laboratory data suggesting bleeding. In all these cases endoscopic reevaluation confirmed the presence of hemorrhage. In this trial, repeated endoscopy was routinely carried out during the first 24 hours to identL~ypatients with rebleeding to repeat the treatment. Only patients with clinical or laboratory data indicative of rebleeding had endoscopic criteria for retreatment and no patients without endoscopic criteria for retreatment had clinical or laboratory evidence of rebleeding. These data are in accordance with the results from a retrospective study of our group suggesting that systematic endoscopic review is not necessary in patients with hemorrhage from gastroduodenal ulcers which have been treated with endoscopic therapy. 2~ Injection therapy and heater probe thermocoagulation have the advantage of safety and portability and are relatively easy to purchase and maintain. We conclude that heater probe thermocoagulation is as effec120 GASTROINTESTINAL ENDOSCOPY
tive and safe as injection therapy in arresting peptic ulcer hemorrhage. REFERENCES 1. Laine L. Multipolar electrocoagulation in the treatment of active upper gastrointestinal tract hemorrhage. A prospective controlled trial. N Engl J Med 1987;316:1613-7. 2. LaineL. Multipolar electrocoagulation in the treatment ofpeptic ulcers with nonbleeding visible vessels: a prospective controlled trial. Ann Intern Med 1989;110:510-4. 3. Rutgeerts P, Vantrappen G, Broeckaert L, Coremans G, Janssens J, Hiele M. Comparison of endoscopic polidocanol injection and YAG laser therapy for bleeding peptic ulcers. Lancet 1989; 1:1164-7. 4. Rutgeerts P, Vantrappen G, Van Hootegem Ph, et al. Neodynium-YAG laser photecoagulation versus multipolar electrocoagulation for the treatment of severely bleeding ulcers: a randomized comparison. Gastrointest Endosc 1987;33:199-202. 5. Goff JS. Bipolar electrocoagulation versus Nd-YAG laser photocoagulation for upper gastrointestinal bleeding lesions. Dig Dis Sci 1986;31:906-10. 6. Laine L. Multipolar electrocoagulationversus injection therapy in the treatment of bleeding peptic ulcers. A prospective randomized trial. Gastroenterology 1990;99:1303-6. 7. Johnston JH, Sones JQ, Long BW, Posey EL. Comparison of heater probe and YAG laser in endoscopic treatment of major bleeding from peptic ulcers. Gastrointest Endosc 1985;31:17580. 8. Jaramillo JL, Carmona C, Galvez C, de la Mata M, Mifio G. Efficacy of the heater probe in peptic ulcer with a non-bleeding visible vessel. A controlled, randomised study. Gut 1993;34: 1502-6. 9. Choudari CP, Rajgopal C, Palmer KR. Comparison of endoscopic injection therapy versus the heater probe in major peptic ulcer hemorrhage. Gut 1992;33:1159-61. 10. Fullerton GM, Birnie GC, MacDonald A, Murray WR. Controlled trial of heater probe treatment in bleeding peptic ulcers. Br J Surg 1989;76:541-4. 11. Lin HJ, Tsai YT, Lee SD, et al. A prospectively randomized trial of heat probe thermocoagulation versus pure alcohol injection in nonvariceal peptic ulcer hemorrhage. Am J Gastroenterol 1988;83:283-6. 12. Lin HJ, Lee FY, Kang WM, Tsai YT, Lee SD, Lee CH. Heat probe thermocoagulation and pure alcohol injection in massive peptic ulcer haemorrhage: a prospective, randomized controlled trial. Gut 1990;31:753-7. 13. Lin HJ, Lee FY, Kang WM, Tsai YT, Lee SD, Lee CH. A controlled study of therapeutic endoscopy for peptic ulcer with non-bleedingvisible vessel. Gastrointest Endosc 1990;36:241-6. 14. Pascu O, Dr~ghici A, Acalovachi I. The effect of endoscopic haemostasis with alcohol on the mortality rate of non variceal upper GI hemorrhage. A randomized prospective study. Endoscopy 1989;21:53-5. 15. Pan~s J, Viver J, Forn~ M, Garcia-Olivares E, Marco C, Garau J. Controlled trial of endoscopic sclerosis in bleeding peptic ulcers. Lancet 1987;2:1292-4. 16. Balanz5 J, Sainz S, Such J, et al. Endoscopic hemostasis by local injection of epinephrine and polidocanol in bleeding ulcer. A prospective randomized trial. Endoscopy 1988;20:289-91. 17. Chung SCS, Leung JWC, Steele RJC, Croi~s TJ, Li AKC. Endoscopic injection of adrenaline for actively bleeding ulcers: a randomized trial. Br Med J 1988;296:1631-3. 18. Pan~s J, Viver J, Forn~ M. Randomized comparison of endoscopic microwave coagulation and endoscopic sclerosis in the treatment of bleeding peptic ulcers. Gastrointest Endosc 1991; 37:611-6. 19. Chung SCS, Leung JWC, Sung JY, Lo KK, Li AKC. Injection or heat probe for bleeding ulcer. Gastroenterology 1991;100: 33-7. 20. Elizalde JI, LLach J, Bordas JM, et al. The value of endoscopic control following sclerotherapy of gastroduodenal peptic lesion. Gastroenterol Hepatel 1994;17:21-3.
VOLUME 43, NO. 2, PART 1, 1996