APC is the standard treatment for GAVE. EBL is an emerging, effective and safe therapeutic modality for GAVE. The rationale for use of EBL is linked to its effect on the submucosal vascular plexus while treatment with APC is mainly directed to lesions in the mucosal layer and this may explain why EBL may theoretically be more effective at obliterating GAVE compared to APC with a more durable response .
This study was conducted to compare the safety and efficacy of combining both APC and EBL in alternating sessions with EBL alone. The idea of combining APC and EBL in alternating sessions is to treat lesions in the mucosal layer with APC then to treat the deeper submucosal resistant lesions using EBL. This may help to gain the benefits of both techniques and reduce the side effects associated with the use of EBL by reducing the number of rubber bands used.
In this prospective randomized study, we compared the efficacy and safety of combination therapy of APC and EBL to EBL alone in 40 cirrhotic patients who suffered from GAVE.
Most of the patients in the two groups showed punctuate (diffuse) type of GAVE which was detected in 17 patients (85%) in the combined therapy group and in 15 patients (75%) in the EBL group. This could be explained by the fact that our patients were cirrhotic and the punctate type is the predominant type of GAVE in cirrhotic patients. This is consistent with previous studies that reported that the punctate type of GAVE is more common in cirrhotics. Punctate type of GAVE was noted in 75% of the patients in the study by Abdelhalim et al., and in 76.5% of the patients in the study by Lecleire et al. [9, 12].
The mean age of cirrhotic patients who presented with GAVE was 57.75 ± 7.51 and 57.35 ± 8.28 in the combined therapy group and EBL group, respectively. This is in agreement with two other similar studies performed on cirrhotic Egyptian patients with a mean age of 54 and 55 years [9, 13]. Other studies reported older age for patients with GAVE .
The younger age of GAVE patients may be related to the higher prevalence of liver cirrhosis in this age group secondary to the high prevalence of HCV in Egypt. All recruited patients were cirrhotic. It was HCV-related in 90% of patients in combined therapy group and 100% in EBL group.
Severe anemia was observed in patients of both groups and this was due to either acute or chronic blood loss from GAVE. This is in agreement with Naga et al. and Zulli et al. who stated that cirrhotic patients with GAVE frequently had significant blood loss and anemia often resulting in repeated transfusion [13, 15].
In our study, the mean value of blood transfusion prior to enrollment in the study was 3.90 ± 2.55 and 3.20 ± 2.24 in the combined therapy group and EBL group, respectively. This value was significantly decreased to a mean value of 0.70 ± 1.98 in the combined therapy group and to 0.95 ± 1.88 in the EBL group with P value = 0.001 after six months of follow up denoting that both approaches are highly effective in controlling bleeding from GAVE.
In our study, treatment of GAVE with EBL had required statistically significant fewer treatment sessions as compared to the combined therapy. This may be explained by the fact that EBL is more effective than APC in obliterating the sub-mucosal plexus of veins and this is reflected on the overall efficacy of the procedure and hence the fewer number of treatment sessions. In a meta-analysis by Chalhoub et al., EBL appears to be both safe and effective in the management of GAVE-related blood loss. The limited literature suggests that compared to endoscopic thermal techniques, the use of EBL is associated with significantly lower transfusion requirements and shows a trend towards more encouraging post-procedural hemoglobin changes and lower number of procedures required to obliterate GAVE. Using EBL in the treatment of GAVE has the potential to reduce the healthcare burdens and costs .
Furthermore, in our study, the use of APC significantly decreased the number of required banding sessions in the combined therapy group as compared to the EBL group (the mean number of banding sessions was 1.5 ± 1.5 in combined therapy group as compared to 1.9 ± 0.76 in EBL group).
The mean number of rubber bands was significantly lower in the combined therapy group than in the EBL group. This may be explained by the fact that APC successfully treats the superficial mucosal lesions and the application of EBL is limited to residual areas which were deeper and refractory to APC.
Patients in both groups showed significantly high rate of bleeding cessation, significant improvement in hemoglobin levels at the end of the follow-up period, and significant reduction in the number of packed red cell transfusions and number of hospitalizations. There was no statistically significant difference regarding the recurrence of GAVE between the two study groups.
Complications of thermal therapies, including APC, in the treatment of GAVE have been reported such as bleeding, perforation, and even death . However, in our study there were no complications seen in the combined therapy group. On the other hand, 20% of the patients in the EBL group had complications including hypertrophied polyp formation and prolonged post-band ulcerations. This was in concordance with previously reported data .
Our results showed that the incidence of complications correlated with the number of applied rubber bands which was significantly lower in the combined therapy group than in the EBL group.
Our study has limitations. Small number of recruited patients makes interpretation of results difficult. All the recruited patients were cirrhotic. Whether our results can be extrapolated to GAVE associated with other medical conditions is not clear and needs validation. Larger head-to-head studies comparing APC, EBL, and combined approaches are needed to confirm our results.