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DOI: 10.1055/s-2000-9617
A Prospective, Randomized Comparison of the Ease and Safety of Variceal Ligation Using a Multiband vs. a Conventional Ligation Device
P. M. Harrison, M.D.
Institute of Liver Studies King's College Hospital
Denmark Hill, London SE5 9RS
United Kingdom
Fax: Fax:+ 44-20-7346-3167
Email: E-mail:phillip.harrison@kcl.ac.uk
Publication History
Publication Date:
31 December 2000 (online)
Background and Study Aims: Recent advances in endoscopic technology have led to the development of multiple-banding devices which avoid the use of an overtube in endoscopic variceal ligation. In the present study we prospectively examined the safety and efficacy of one such device compared with the conventional single-band ligator.
Patients and Methods: A total of 45 patients undergoing band ligation were randomly assigned to receive ligation using conventional techniques (n = 22), or multiband ligation (n = 23).
Results: The use of the multiband device was associated with a significant reduction in sedation requirements (midazolam 7.1 mg vs. 9.9 mg, P < 0,01, multiband vs. conventional, respectively), less discomfort (4 % vs. 23 % severe discomfort, P < 0.05). The total time of the endoscopic session was reduced in the multiband group (8 minutes 25 seconds vs. 12 minutes 21 seconds, P < 0.01), as was the time required for application of all the bands (2 minutes 22 seconds vs. 5 minutes 34 seconds, P < 0.001), and average time taken per individual band application (36 seconds vs. 1 minute 36 secs, P < 0.01). In three patients who underwent ligation using the conventional method, the procedure was stopped because of trauma secondary to overtube application.
Conclusions: Multiband ligation is safer, quicker, and associated with less patient discomfort and morbidity when compared with conventional ligation.
#Introduction
Band ligation is superior to sclerotherapy for the treatment of oesophageal varices in terms of time to variceal obliteration, rebleeding rate, oesophageal stricturing, oesophageal ulceration and mortality [1] [2] [3] [4] [5] . However, complications can arise from the instrumentation procedure used in variceal ligation. In contrast to injection sclerotherapy, repeated intubations are required for the placement of multiple bands using the conventional ligator, a procedure that is time consuming and necessitates overtube insertion. The insertion of the overtube also causes trauma, and in some cases oesophageal perforation [6] [7] [8] [9] [10] [11] . Recently, multiple-banding devices have been developed which allow several bands to be applied during a single endoscopic insertion, without the need for overtube placement. However, there have been few studies on the safety and efficacy of these devices. In the present study, we prospectively compared the safety and speed of one such multiple-banding device, which allows five bands to be applied at a single insertion, with the conventional “single-shot” ligation device in the treatment of bleeding oesophageal varices. In particular, the time taken for band ligation, discomfort experienced by the patient and damage to the upper oesophagus were compared between the mulitple-banding device and the conventional ligation device.
#Patients and Methods
#Patients
The Institute of Liver Studies, King's College Hospital, is a tertiary hepatology/liver transplantation centre, performing approximately 400 endoscopic ligation sessions per year. Up until 1996 the conventional band ligator was used as the standard therapy for oesophageal varices. In early 1996, the multiband ligator was introduced at King's College Hospital. A total of 45 patients (31 men, 14 women; average age 50, range 26 - 74) were randomly assigned to receive banding using either the conventional device (n = 22), or the multiband ligator (n = 23) over a 7-month period between May and November 1996. Of the 45 patients, 29 (65 %) were Child-Pugh class A, 11 (24 %) were class B and 5 (11 %) were class C. The aetiology for portal hypertension comprised alcoholic liver disease (n = 19), hepatitis C cirrhosis (n = 6), cryptogenic cirrhosis (n = 5), primary biliary cirrhosis (n = 3), autoimmune hepatitis (n = 2), congenital hepatic fibrosis (n = 2), secondary biliary cirrhosis (n = 1), hepatitis B cirrhosis (n = 2), non-cirrhotic portal hypertension (n = 1), portal vein thrombosis (n = 2), primary sclerosing cholangitis (n = 1) and nodular regenerative hyperplasia (n = 1) (Table [1]). None of the patients suffered an active variceal haemorrhage at the time of ligation. In total 160 bands were applied, with a median of four bands applied at each session (range 1 - 8).
#Endoscopic Variceal Band Ligation
All endoscopists were experienced both in conventional single-shot ligation and in the use ot the multiband ligator. Endoscopic therapy was undertaken with intravenous sedation (midazolam and pethidine), the dose of which was titrated according to patient requirements. Nasal oxygenation was given, and patients were monitored with pulse oximetry. Olympus Q200 endoscopes (Keymed, Southend-on-Sea, U.K.) were used in all procedures. At each endoscopic examination a primary endoscopic survey of the oesophagus and stomach was performed. At this examination varices were graded according to size: grade 1 (< 3 mm), grade 2 (4 - 6 mm), grade 3 (7 - 10 mm) and grade 4 (> 10 mm). The endoscope was then withdrawn, and the appropriate banding device was loaded. Single-shot endoscopic variceal banding ligation was performed according to previously published techniques [2]. Briefly, this was done using the newly designed overtube (60 Fr, 20 cm) and a ligating device (Bard Interventional Products, Tewksbury, Massachusetts, United States). Varices were ligated individually with single elastic rings at the oesophagogastric junction, and continued up the oesophagus for 4 - 5 cm. In between each ligation the endoscope was withdrawn, and a new band was loaded onto the endoscope. After the final band was applied the overtube was withdrawn, and the oesophagus inspected for damage during withdrawal of the endoscope. Multiple banding was performed using the “Speedband” ligator (Boston Scientific, Natick, Massachusetts, United States). This technique involves the loading of the multiband device onto the endoscope, with the bands applied to individual varices during one single intubation. If more than five bands were required a second ligation device was used. After the completion of banding the upper oesophagus was inspected for damage. Data on sedation requirements, upper oesophageal damage, patient discomfort, ease of intubation, immediate band retention and time parameters were prospectively collected. Specifically midazolam was used routinely as intravenous sedation, and the dosage was titrated to relieve patient discomfort as judged by the endoscopist. Pethidine was given at the discretion of the operating endoscopist. Upper oesophageal damage was classified on a scale of 1 to 3 (1 = oesophageal hyperaemia, 2 = haematoma, 3 = haemorrhage and rupture) by an independent observer at the time of endoscopy. Patient discomtort was judged by the operating endoscopist according to a scale of 1 to 3 (mild, moderate or severe). The ease of intubation was judged on the first intubation for the conventional ligator, and on the second intubation in the case of the multibander, and was judged by the endoscopist on a scale of 1 to 5. The time taken to perform the total endoscopic procedure, the primary survey, the application of the banding device, and second intubation, all band applications and the average time taken to apply each band were measured.
Statistics. Differences between groups were evaluated using the nonparametric Mann-Whitney U-statistic, and the chi-squared test with continuity correction where appropriate. Differences between groups were considered significant when P < 0.05. Calculations were performed using the SPSS program for Windows version 6.1.
#Results
Of the 45 patients, 23 were banded using the multiband ligator, and 22 using the conventional ligator device. The two groups were well matched with respect to age (52 vs. 49, respectively), Child-Pugh score (70 % vs. 59 % grade A), number of varices (median 3 vs. 3), grade of varices (median 2 vs. 2) and number of bands applied (4 vs. 4) (Table [2]). When sedation usage was compared between the groups, less sedation was found to be required for those banded with the multiple-ligator device. The midazolam requirement was lower (mean 7.1 mg vs. 9.9 mg, P < 0.01), and there was a trend towards a lower pethidine requirement (10.9 mg vs. 22.7 mg, P = 0.15) (Table [3]). Despite the reduced sedation requirements in the multiband group, there was a lower patient-discomfort score in the multiband group when compared with the conventional banding group; 20 of the 23 patients banded with the multibander appeared to be in only mild discomfort (87 %), two had moderate discomfort (9 %) and one had severe discomfort (4 %) during the procedure, compared with 13 (59 %) suffering mild discomfort, four moderate discomfort (18 %), and five severe discomfort (23 %) in the 22 patients banded with the conventional single-shot method (P < 0.05). The degree of upper oesophageal trauma caused by the multiple-ligator device was significantly less than that associated with the use of the overtube during conventional banding. In 16 (70 %) of the 23 patients banded with the multiligator there was no visible upper oesophageal damage, hyperaemia was present in six (26 %) and 1 (4 %) suffered an upper oesophageal haematoma. In contrast, only 11 (50 %) of the patients who underwent conventional banding had no evidence of upper oesophageal damage, while upper oesophageal hyperaemia and haematoma were present in seven (32 %) and two (9 %) of the patients, respectively. Upper oesophageal haemorrhage or perforation occurred in two of the 22 patients (9 %). In two patients who underwent ligation using the conventional banding device the procedure was prematurely stopped because of upper oesophageal trauma, and one further patient died from an oesophageal rupture subsequent to overtube application. No such complication occurred in the multiband group. The multiligator device proved superior to the conventional banding device with respect to all time parameters examined. The time taken to perform the entire endoscopic procedure (8 minutes 25 seconds vs. 12 minutes 21 seconds, P < 0.01), the time taken to band each varix (36 seconds vs. 1 minute 36 seconds, P < 0.001) and the time taken to band all the varices (2 minutes 22 seconds vs. 5 minutes 34 seconds, P < 0.001) were all reduced in the multiband group. The time taken to load the ligator device and perform the second intubation was slightly longer in the multiligator device when compared with the single-shot bander (2 minutes 51 seconds vs. 2 minutes 2 seconds, P < 0.05).
#Discussion
The findings of the present study that the multiband ligator device is quicker to use and associated with less trauma and discomfort than the conventional Stiegmann-Goff ligator are consistent with the results of previous preliminary studies using other multiband devices [12]. These advantages may be attributed to the use of the overtube in the conventional Stiegmann-Goff ligator. There have been many reports of overtube-related injuries, including upper oesophageal rupture and haemorrhage from upper oesophageal varices [6] [7] [8] [10] [11] [13] . In the present study, the rate of oesophageal trauma was lower than in the series reported by Dennert et al. [13], a result attributable to a different method of grading oesophageal trauma. Despite this, there was a marked reduction in the rate of upper oesophageal injury in the multiband group. Since the multiligator devices do not require multiple intubations, the use of the overtube is unnecessary and these complications are reduced. In the present series one patient died from an oesophageal rupture secondary to overtube usage, and in two patients overtube injuries caused the procedure to be abandoned. There have been some reports of safer techniques of overtube insertion, including the use of a bougie device [14], and the possibility of a reduction in overtube-related complications with this device has been proposed. In our experience, however, this device causes similar discomfort to using an overtube alone. An additional advantage of the multiligator device is the reduction in the time taken for the banding procedure, both for the banding phase and the total time taken to perform the session. Again this is consistent with studies of other multiligator banding devices, with one previous study of the “Saeed Six-Shooter” showing similar advantages over conventional banding with respect to time parameters [12]. We have not found any disadvantage associated with possible reduction in the field of vision using the multiband device when compared with the single-shot ligator in patients undergoing variceal eradication as secondary prophylaxis; the ease of visual identification of varices is reflected in the time taken to band each varix.
In conclusion, multiligator devices represent a significant advance in banding technology, improving the safety and tolerance of the procedure and reducing operator time. The higher cost of the multiband device when compared with the conventional single ligator is off set by these advantages. There are now several multiligator devices available, and the advantage of all of them is that they render the overtube redundant. It is likely that any differences between these devices will be marginal. The improved safety and speed of these multiligator banding devices lead to our current recommendation, which is that they be the equipment of choice for the endoscopic ligation of oesophageal varices.
| Group (n) | Men : Women | Aetiology (n) | Mean age (range) | Child-Pugh class | ||
| A | B | C | ||||
| Conventional banding (22) | 17 : 5 | Autoimmune hepatitis (1) | 49 (32 - 74) | 13 | 6 | 3 |
| Alcoholic liver disease (11) | ||||||
| Congenital hepatic fibrosis (2) | ||||||
| Cryptogenic cirrhosis (2) | ||||||
| Hepatitis B cirrhosis (1) | ||||||
| Hepatitis C cirrhosis (3) | ||||||
| Primary biliary cirrhosis (1) | ||||||
| Portal vein thrombosis (1) | ||||||
| Multibanding (23) | 14 : 9 | Autoimmune hepatitis (1) | 52 (26 - 69) | 16 | 5 | 2 |
| Alcoholic liver disease (8) | ||||||
| Cryptogenic cirrhosis (3) | ||||||
| Hepatitis B cirrhosis (1) | ||||||
| Hepatitis C cirrhosis (3) | ||||||
| Noncirrhotic portal hypertension (1) | ||||||
| Nodular regenerative hyperplasia (1) | ||||||
| Primary biliary cirrhosis (2) | ||||||
| Primary sclerosing cholangitis (1) | ||||||
| Portal vein thrombosis (1) | ||||||
| Secondary biliary cirrhosis (1) | ||||||
| Multibanding | Conventional banding | |
| n = 23 | n = 22 | |
| Child grade (%) | ||
| A | 16 (70) | 13 (59) |
| B | 5 (22) | 6 (27) |
| C | 2 (9) | 3 (14) |
| Number of varices (%) | ||
| 1 | 1 (4) | 1 (5) |
| 2 | 2 (9) | 3 (14) |
| 3 | 10 (43) | 10 (45) |
| 4 | 9 (39) | 4 (18) |
| 5 | 1 (4) | 4 (18) |
| Grade of varices (%) | ||
| 1 | 9 (39) | 11 (50) |
| 2 | 6 (26) | 8 (36) |
| 3 | 8 (35) | 3 (14) |
| Number of bands applied (%) | ||
| 2 | 3 (13) | 6 (27) |
| 3 | 5 (22) | 4 (18) |
| 4 | 4 (17) | 5 (23) |
| 5 or more | 11 (48) | 4 (18) |
| Procedure abandoned (%) | 0 | 3 (14) |
| Multiband | Conventional banding | P | |
| (n = 23) | (n = 22) | ||
| Midazolam requirement, mg | 7.1 | 9.9 | < 0.01 |
| Pethidine requirement, mg | 10.9 | 22.7 | 0.15 |
| Upper oesophageal damage (%) | |||
| None | 16 (70) | 11 (50) | 0.07 |
| Hyperaemia | 6 (26) | 7 (32) | |
| Haematoma | 1 (4) | 2 (9) | |
| Haemorrhage or perforation | 0 | 2 (9) | |
| Patient discomfort (%) | |||
| Mild | 20 (87) | 13 (59) | < 0.05 |
| Moderate | 2 (9) | 4 (18) | |
| Severe | 1 (4) | 5 (23) | |
| Time parameters, mean (range) | |||
| Entire procedure | 8 min 25 s (20 min - 3 min 2 s) | 12 min 21 s (30 min - 5 min) | < 0.01 |
| From first to last ligation | 2 min 22 s (12 min 50 s - 2 min) | 5 min 34 s (9 min 15 s - 10s) | < 0.001 |
| For each ligation | 30 s (1 min 51 s - 8 s) | 1 min 36 s (3 min 5 s - 40 s) | < 0.001 |
References
- 1 Laine L. Ligation: endoscopic treatment of choice for patients with bleeding esophageal varices (editorial)?. Hepatology. 1995; 22 663-665
- 2 Stiegmann G V, Goff J S, Michaletz-Onody P A, et al. Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N Engl J Med. 1992; 326 1527-1532
- 3 Gimson A E, Ramage J K, Panos M Z, et al. Randomised trial of variceal banding ligation versus injection sclerotherapy for bleeding oesophageal varices (see comments). Lancet. 1993; 342 391-394
- 4 Hou M C, Lin H C, Kuo B I, et al. Comparison of endoscopic variceal injection sclerotherapy and ligation for the treatment of esophageal variceal hemorrhage: a prospective randomized trial. Hepatology. 1995; 21 1517-1522
- 5 Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding: A meta-analysis. Ann Intern Med. 1995; 123 280-287
- 6 Holderman W H, Etzkorn K P, Patel S A, et al. Endoscopic findings and overtube-related complications associated with esophageal variceal ligation. J Clin Gastroenterol. 1995; 21 91-94
- 7 Hoepffner N, Foerster E, Menzel J, et al. Severe complications arising from oesophageal varix ligation with the Stiegmann-Goff set. Endoscopy. 1995; 27 345
- 8 Hou M C, Lin H C, Chang F Y, et al. Oesophageal perforation following endoscopic variceal ligation and balloon tamponade. J Gastroenterol Hepatol. 1994; 9 659-662
- 9 Minoli G. Esophageal perforation and variceal banding (letter). Endoscopy. 1994; 26 633
- 10 Schoonbroodt D, Zipf A, Jung M. Local necrosis and fatal perforation of oesophagus after endoscopic ligation (letter). Lancet. 1994; 344 1365
- 11 Johnson P A, Campbell D R, Antonson C W, et al. Complications associated with endoscopic band ligation of esophageal varices. Gastrointest Endosc. 1993; 39 181-185
- 12 Saeed Z A. The Saeed Six-Shooter: a prospective study of a new endoscopic multiple rubber-band ligator for the treatment of varices. Endoscopy. 1996; 28 559-564
- 13 Dennert B, Ramirez F C, Sanowski R A. A prospective evaluation of the spectrum of overtube-related esophageal mucosal injury. Gastrointest Endosc. 1997; 45 134-137
- 14 Goldschmiedt M, Haber G, Kandel G, et al. A safety maneuver for placing overtubes during endoscopic variceal ligation (letter). Gastrointest Endosc. 1992; 38 399-400
P. M. Harrison, M.D.
Institute of Liver Studies King's College Hospital
Denmark Hill, London SE5 9RS
United Kingdom
Fax: Fax:+ 44-20-7346-3167
Email: E-mail:phillip.harrison@kcl.ac.uk
References
- 1 Laine L. Ligation: endoscopic treatment of choice for patients with bleeding esophageal varices (editorial)?. Hepatology. 1995; 22 663-665
- 2 Stiegmann G V, Goff J S, Michaletz-Onody P A, et al. Endoscopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N Engl J Med. 1992; 326 1527-1532
- 3 Gimson A E, Ramage J K, Panos M Z, et al. Randomised trial of variceal banding ligation versus injection sclerotherapy for bleeding oesophageal varices (see comments). Lancet. 1993; 342 391-394
- 4 Hou M C, Lin H C, Kuo B I, et al. Comparison of endoscopic variceal injection sclerotherapy and ligation for the treatment of esophageal variceal hemorrhage: a prospective randomized trial. Hepatology. 1995; 21 1517-1522
- 5 Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal variceal bleeding: A meta-analysis. Ann Intern Med. 1995; 123 280-287
- 6 Holderman W H, Etzkorn K P, Patel S A, et al. Endoscopic findings and overtube-related complications associated with esophageal variceal ligation. J Clin Gastroenterol. 1995; 21 91-94
- 7 Hoepffner N, Foerster E, Menzel J, et al. Severe complications arising from oesophageal varix ligation with the Stiegmann-Goff set. Endoscopy. 1995; 27 345
- 8 Hou M C, Lin H C, Chang F Y, et al. Oesophageal perforation following endoscopic variceal ligation and balloon tamponade. J Gastroenterol Hepatol. 1994; 9 659-662
- 9 Minoli G. Esophageal perforation and variceal banding (letter). Endoscopy. 1994; 26 633
- 10 Schoonbroodt D, Zipf A, Jung M. Local necrosis and fatal perforation of oesophagus after endoscopic ligation (letter). Lancet. 1994; 344 1365
- 11 Johnson P A, Campbell D R, Antonson C W, et al. Complications associated with endoscopic band ligation of esophageal varices. Gastrointest Endosc. 1993; 39 181-185
- 12 Saeed Z A. The Saeed Six-Shooter: a prospective study of a new endoscopic multiple rubber-band ligator for the treatment of varices. Endoscopy. 1996; 28 559-564
- 13 Dennert B, Ramirez F C, Sanowski R A. A prospective evaluation of the spectrum of overtube-related esophageal mucosal injury. Gastrointest Endosc. 1997; 45 134-137
- 14 Goldschmiedt M, Haber G, Kandel G, et al. A safety maneuver for placing overtubes during endoscopic variceal ligation (letter). Gastrointest Endosc. 1992; 38 399-400
P. M. Harrison, M.D.
Institute of Liver Studies King's College Hospital
Denmark Hill, London SE5 9RS
United Kingdom
Fax: Fax:+ 44-20-7346-3167
Email: E-mail:phillip.harrison@kcl.ac.uk