The research study is an analysis of the benefits of endoscopic band ligation over argon plasma coagulation in the treatment of gastric antral and fundal vascular ectasia. According to research, GAVE is a serious consequence of cirrhosis. Several medicinal, surgical, and endoscopic therapy approaches have been offered, with varying degrees of success. Gastric antral vascular ectasia (GAVE) is typically detected in patients with cirrhosis. The estimated prevalence in cirrhotic patients with upper GI bleeding is around 6%, whereas it is roughly 12% in cirrhotic patients without obvious upper GI hemorrhage. Another study discovered GAVE in 1 in 40 cirrhotic patients who had screening esophagogastroduodenoscopy (EGD) during liver transplant evaluation. Hidden bleeding to transfusion-dependent chronic iron deficiency anemia are all clinical manifestations. In earlier studies, the prevalence of GAVE in SSC ranged from 5% to 14%, but a recent retrospective analysis of a European patient database found GAVE in only 1% of SSc patients.
Rationale for Choosing the Topic
The critical analysis of this study will show that Endoscopic Banding Ligation (ELB) is a better therapeutic approach to gastroesophageal varies and GAVE, compared to Argon Plasma Coagulation or injection sclerotherapy (APC). It will encourage Endoscopists to consider Endoscopic Banding Ligation as the first line of treatment because it is the safest and most effective intervention. It reduces the risk of harm associated with the other options available. Consideration and implementation of this will influence better practice and impact quality improvement in terms of safety, effectiveness, and efficacy.
Description of the Bibliographic Search
Elhendawy, M. et al. (2016) ‘Randomized controlled study of endoscopic band ligation and argon plasma coagulation in the treatment of gastric antral and fundal vascular ectasia,’ United European gastroenterology journal, 4(3), pp.423-428. Web.
This paper presents the findings of a randomized controlled study of endoscopic and argon plasma coagulation in the treatment of gastric antral and fundal vascular ectasia. The purpose of this randomized controlled trial was to compare the safety and efficacy of EBL to APC in the treatment of GAVE and gastric fundal vascular ectasia. The paper identifies that in individuals with cirrhosis, gastric antral vascular ectasia (GAVE) is characterized by mucosal and submucosal vascular ectasia, resulting in recurrent hemorrhage and hence chronic anemia. Treatment with argon plasma coagulation (APC) is successful and safe, however it necessitates many endoscopic sessions. The research involved 88 cirrhotic patients with GAVE. The patients were dived into two groups and randomized to endoscopic treatment with either EBL or APC as per the group. The endoscopic treatment took place at an interval of two weeks until complete obliteration was achieved. Thereafter, an endoscopic follow up was conducted after six months in addition to a monthly measurement of the hemoglobin during the period.
The paper discovered that EBL considerably reduced the number of sessions necessary for complete obliteration of the lesions (2.98 versus 3.48 in the APC group (p 0.05). Hemoglobin levels increased significantly after obliteration of the lesions in both groups, compared to pretreatment values (p < 0.05), but with no significant difference between the two groups (p > 0.05); however, the EBL group of patients required a significantly smaller number of units of blood transfusion than the APC group of patients (p < 0.05). There were no significant differences between the two groups in terms of adverse events or complications (p > 0.05). Therefore, I chose this particular research paper because it documents and histologically proves the occurrence of GFVE concurrently with GAVE in cirrhotic patients. The paper demonstrates that EBL or APC can successfully manage GAVE. In the treatment of GAVE and GFVE in cirrhotic patients, the study found that EBL is more effective and safer than APC.
Application of the Chosen Critical Framework to the Research Paper
The research study addressed a clearly focused issue on health. It involved 88 cirrhotic patients who suffered from gastric antral and fundal vascular ectasia admitted to the departments of Tropical Medicine and Internal Medicine between the periods of December 2012 to December 2013. The study histologically proves and documents the occurrence of GFVE concurrently with GAVE in cirrhotic patients. The researchers demonstrated that EBL or APC can successfully manage GFVE. In the treatment of GAVE and GFVE in cirrhotic patients, it found that EBL is more effective and safer than APC. The trial provides a number of comparative studies previously conducted on the same issue. Some of the comparators provided include, an observational and comparative researches which elaborated on the superiority of EBL over endoscopic thermal therapy (ETT) (Elhendawy et al., 2016). Some of the advantages of EBL over ETT as found by Wels et al. included decrease of treatment sessions, control of bleeding, time of hospitalization, requirement for transfusion and increase in hemoglobin values.
The current study concurs with the findings from previous research and shows that that EBL significantly reduced the need for transfusion, compared to APC. Previous studies have shown that to avoid the high recurrence rate following APC, EBL may be effective in the treatment of GAVE. (Elhendawy et al., 2016). The researchers have documented and anatomically established the presence of GFVE in 20.5-29.5% of their GAVE patients. According to the randomization, it was successfully treated with the same treatment modalities. However, the research recommends that the lesions should be sought out with caution, as it has chances of contributing to more bleeding and anemia.
The assignment of patients to the treatment was randomized. The sample size of 88 patients was divided into two groups each containing 44 patients based on a previous study. One group was treated using the EBL process while the other group was treated using the APC process. This ensured that the treatment of GAVE associated with liver diseases with EBL had a mean of 3 (SD 0.9) sessions, compared to 2.3 (SD 0.9) sessions with APC; with a power of 90% and a significance level of 5%. (2-sided).
All the patients who entered the test were properly accounted for at the conclusion. At the beginning of the research study, a total of 94 patients were enrolled. All the patients had GAVE associated with liver diseases. The study reports 88 patients to have successfully completed the study project with six patients out of the 94 excluded since they declined to participate. However, the study does not give a breakdown analysis of the patients’ examination and results, therefore, making it had to confirm whether every patient was accounted for at the end of the study; it only provides a general analysis of the results. The patients were sequentially randomized to endoscopic treatment with either EBL or APC every 2 weeks until complete annihilation was achieved; they were then endoscopically followed up on after 6 months, with monthly hemoglobin levels measured.
The groups were similar at first. There were no significant statistical differences in terms of age, gender, race, the presence of diabetes or hypertension. According to the demographic and endoscopic profiles of the studies groups, the mean age for the EBL group was 51.41 while that of APC group was 53.09 both with a deviation of plus or minus seven. EBL group had 19 male patients and 25 female patients while the APC group had 15 male patients and 29 female patients. The Hypertension percentage in EBL group was 9.1% while that for the APC group was 18.2 percent. The percentage of patients with Diabetes Mellitus (DM) in EBL group was 25 percent while that of APC group was 31.8 percent.
There were two patients classified in Child Pugh Class A and in EBL group while there was no patient under the Class A Child Pugh in APC group. There were 22 patients from EBL group under the Child Pugh Class B while there were 23 patients under Child Pugh Class B in the APC group. There were 20 patients classified under Child Pugh Class C in the EBL group while there were 21 from APC group. The mean score of the participants from the EBL group was 9.46 with a deviation of plus or minus 1.72. On the other hand, the mean score for the participants from the APC group was 9.52 with a deviation of plus or minus 1.69. There was no significant difference between the groups in terms of the existence of esophageal varices (EV) and the history of previous endoscopic therapy for EV (p > 0.05). GFVE was identified in 13 out of 44 EBL patients (29.5%) and 9 out of 44 APC patients (20.5%), with no statistically significant difference (p > 0.05). Histopathologic investigation revealed comparable pathologic findings of dilated capillaries in the submucosa of the GFVE and GAVE lesions.
According to the research, the EBL group demonstrated a significant lower number of treatment sessions as compared to the ABC group. The EBL group had a mean of 2.93 treatment sessions while the APC group had a mean of 3.48 treatment sessions. Secondly, the EBL group showed a significantly better response to treatment than the APC group. The average hemoglobin levels in the EBL group increased from 6.73 0.991 (range: 5-9 gm/dL) before therapy to 10.31 1.01 (range: 8.5-12 gm/dL) after treatment, which was statistically significant (p 0.001). In the APC group, hemoglobin levels increased from 6.72 0.905 (range 5-9 gm/dL) before treatment, to 9.85 0.906 (range 8-11 gm/dL) after treatment; and the difference was statistically significant (p < 0.001). A comparison of hemoglobin levels in the two groups before and after therapy revealed no significant difference (p > 0.05). The patients of the EBL group required a considerably lower number of blood units transfused than in the APC group, with a mean of 2.5 units versus 4.6 units, respectively (p ¼ 0.033). Mild adverse events were reported in six of the 44 patients (13.6%) in the EBL group, including fever in two, mild bleeding from a post-band ulcer in one, and epigastric pain in three. In the APC group, 9 out of 44 patients (20.5%) suffered adverse events, in the form of fever in two patients, abdominal distension in four patients and epigastric discomfort in three per patient. No statistically significant change was discovered (p > 0.05).
The study detailed and histologically demonstrated the presence of GFVE in cirrhotic individuals, and that GFVE can be successfully controlled by EBL or APC. In the treatment of GAVE and GFVE in cirrhotic patients, the research found that EBL was more successful and safer than APC. The researchers characterized and confirmed the presence of GFVE in 20.5-29.5% of the GAVE participants. It was successfully treated with the same treatment techniques, according to randomization. They propose that this lesion should be examined for carefully, as they believe it may contribute to additional bleeding and anemia. They do not know if GFVE can be present without GAVE, so more research is needed to determine if GFVE can be present alone and if GFVE can be present in noncirrhotic patients. The study’s weaknesses were that it did not broaden the comparison parameters, such as procedure duration, length of hospital stay, patient satisfaction, how quality of life was influenced, cost effectiveness, or have a longer follow-up period.
Based on the analysis, the results can be applied to the local population to obtain the required outcome. The participants in the experiment were elderly people of an average age of 55 years and were all of them were patients with liver related diseases. According to statistics, GAVE is more prevalent among elderly people especially women of age 70 years and above. GAVE is also common among patients with Cirrhosis. Cirrhosis is most common in people aged 45 to 64 (0.56% and 0.29%, respectively, based on hospital and medical claims. When the US population is considered, patients with health insurance in 2018, 792,184 and 432,991 persons were predicted to have cirrhosis based on hospital and medical claims, respectively. 17.97% of all hospital claims and 44.18% of all medical claims were included in the APLD claims database. In addition, GAVE appears to be more prevalent in SSc patients with anti-RNA-polymerase III antibodies and less prevalent in those with antitopoisomerase I antibodies, and it may be more prevalent in those with diffuse cutaneous SSc.
Endoscopic band ligation (EBL) is the most often used endoscopic procedure for treating acute esophageal variceal bleeding. EBL has further been used to treat nonvariceal hemorrhage. Elhendawy et al have elaborately established that EBL can be a practical and safe therapeutic approach for the management of iatrogenic stomach perforation notably in cases in which closure using endoclips is challenging. According the researchers, the approach has proven effective and efficient in enabling management of the condition. EBL is technically simpler to conduct than other procedures and allows a good view of the lesions under direct pressure and suction from the transparent ligation cap. EBL can be employed even if the diameter of the perforation is higher than 10 mm or if there is a severe tangential angle.
In summary, GAVE is still a difficult illness to manage, with many patients in need of transfusions after iron supplementation. As the actual etiology of GAVE remains unknown, numerous therapeutic techniques have been tested. While medication has been demonstrated to be unsuccessful for GAVE, endoscopic management has typically been the primary therapeutic approach, most often using thermal-based treatments such as APC and, less commonly, RFA (Fortinsky and Barkun, 2019). Yet, based upon this latest systematic review and meta-analysis, EBL looks to be a successful treatment for GAVE.
This study can be used to improve health and care quality through various ways. Firstly, it emphasizes on application of EBL as the first therapeutic approach to gastroesophageal varies and GAVE hence improving the outcomes of treatment. In terms of endoscopic eradication rates, recurrence of bleeding, and transfusion requirements, the systematic review and meta-analysis revealed that EBL outperforms APC. Secondly, the application of EBL is safe and effective primary and recurrent option for the treatment of GAVE. Despite the fact that APC thermal therapy is a first-line treatment method, this systematic review and meta-analysis found that EBL is related with a higher rate of ectasia eradication, a higher rise in post-procedure hemoglobin, and a lower incidence of rebleeding (McCarty et al., 2021). This increased endoscopic success rate was obtained with fewer treatment sessions as well, with no difference in side effects compared to APC.
Endoscopic therapy of GAVE with radiofrequency ablation (RFA) may have superior effectiveness and tolerance when compared to APC, perhaps because to differences in thermal approach. RFA includes delivering a high frequency alternating electrical current to tissue, which may produce a more regulated depth of thermal coagulative necrosis than APC, which is a non-contact approach with a more variable depth of coagulation 50 52. Given the submucosal involvement of GAVE, it stands to reason that EBL may deliver better or similar results, enhanced endoscopic success, and fewer treatment sessions.
Lastly, this study can improve the health and care quality by reducing the cost of treatment of gastroesophageal varies and GAVE. These findings, which include better operator-reported endoscopic success, fewer endoscopic treatment sessions required, reduced adverse event rates, and familiarity with the band ligation device, indicate that EBL may be a more cost-effective therapy for GAVE patients. However, there is currently no cost-effectiveness evidence to back up this assertion. EBL has always been thought of as a salvage therapy for patients who did not respond to earlier APC treatment. While 37.80% of the patients in this meta-analysis had GAVE that was resistant to APC, the majority of patients underwent EBL therapy without prior thermal treatment, suggesting that EBL might be used as an early therapeutic option for GAVE.
Reference List
Elhendawy, M., Mosaad, S., Alkhalawany, W., Abo-Ali, L., Enaba, M., Elsaka, A. and Elfert, A.A., 2016. ‘Randomized controlled study of endoscopic band ligation and argon plasma coagulation in the treatment of gastric antral and fundal vascular ectasia.’ United European gastroenterology journal, 4(3), pp. 423-428. Web.
McCarty, T.R., Hathorn, K.E., Chan, W.W. and Jajoo, K. (2021) ‘Endoscopic band ligation in the treatment of gastric antral vascular ectasia: A systematic review and meta-analysis,’ Endoscopy International Open, 9(07), pp. E1145-E1157. Web.
Appendix: Demographic and Endoscopic Profile of the Studied Groups
Table 1
HTN, hypertension; DM, diabetes mellitus; APC, argon plasma coagulation; EBL, endoscopic band ligation; EV, esophageal varices; GAVE, gastric antral vascular ectasia. P < 0.05 *significant.