This is a large retrospective multicenter study conducted in 11 hospitals to investigate the frequency of device-related AEs and AEs associated with PEG-J tube replacement timing during LCIG treatment. In this study, PEG-J was successfully and safely inserted in all patients.
However, a high rate of AEs was reported in not only PEG-J insertion for enteral nutrition12–16 but also for LCIG treatment.10, 17–20 Furthermore, studies describing AE details and ways to deal with them are limited. Therefore, this study clarifies details of LCIG-related AEs, including the frequency and timing of their occurrence and ways to manage them. Several studies have reported that the incidence was 47.2–87.5% for any AEs related to the LCIG treatment and 17–44% for major AEs related the LCIG treatment.10, 17–20 On the contrary, in this study, 29.4% (n = 30) of patients had minor and 43.1 % (n = 44) had major AEs as in previous reports.
The incidence rate of AEs in all patients was 72.5% (n = 74). The incidence rate of AEs related to tube problems such as tube dislocation, tube kinking, tube occlusion, and tube breakage was 70.2% (n = 73), of which 32.9% (n = 24) were treated with vigorous saline flushing and/or declogging of the PEG-J tube with an inserted guidewire agitated back and forth. The remaining (67.1%, n = 49 cases) AEs related to tube problems were treated with PEG-J tube exchange using endoscopy or fluoroscopy. Other studies demonstrated that most of the procedure/device-related AEs reported by patients who had a PEG-J placement in these studies were consistent in nature and incidence, with medically recognized AEs of the procedure in non-PD patient populations.10, 17–25
In our study, major AEs were observed in 43.1% (n = 44) of all patients. Among these events, only few were severe and required surgical treatment and most major AEs were treated endoscopically such as with tube exchange.
Therefore, we can say that only 2.7% (n = 2 cases) of the AEs were notable serious AEs and the remaining 97.3% of the AEs could be treated with simple procedures such as vigorous saline flushing or endoscopic tube exchange in this study. Serious AEs occurred in 2.0% (n = 2 cases) of all the cases, which indicates that the LCIG treatment was safe and feasible.
The bezoar formation can be a problem during LCIG treatment due to the need for long-term placement of PEG-J tubes. AEs with bezoar, which is a mass of indigestible ingested particles accumulated over time in the gastrointestinal system, were reported in patients who received LCIG treatment.26 Bezoar can cause pressure ulcers, obstruction of the gastrointestinal tract, or difficulty to remove the PEG-J tube due to adhesion of the bezoar to the intestinal wall. In fact, two cases of bezoar were observed in this study. In these two patients, bezoar was formed at the tip of the tube. The tip of the PEG-J tube of the LCIG treatment system is pigtail-shaped. This shape may easily trap food residues, causing a bezoar. Especially, Japanese foods contain a large amount of non-digestible fibers such as soybeans, sweet potato, burdock, cabbage, mushrooms, and seaweed. A bezoar is composed of these non-digestible fibers.26, 27 This is the reason why Japanese people should be careful of bezoar formation during LCIG treatment. Probably, the best way to prevent this complication is to maintain a low-fiber diet.26 Especially in cases with long-term PEG-J tube placement such as in LCIG treatment, attention should be paid to the possibility of bezoar formation, and patients receiving LCIG treatment should be advised to avoid fiber-rich diets.
At the end of the first year, 54.9% of patients retained the original PEG-J tube, and at the end of the second year, 22.5% retained the original PEG-J tube.
The original PEG-J tube retention rates reported in other studies were 63% and 49% at the end of the first and second years, respectively, and the PEG-J tube retention rate in the present study tended to be shorter than those in other studies.17, 20 However, even in this study, the PEG-J tube retention rate after 1 year was 65.1% in the analysis, excluding patients with scheduled replacement. In Japan, this may have affected the tube retention rate because some facilities regularly exchange tubes even without AEs.
A total of 53 patients had their tubes replaced one or more times. The mean replacement period was 10.4 months, i.e., 11.0 months for patients with scheduled replacement and 10.2 months for patients who had to undergo replacement due to AEs. No statistically significant difference was observed in terms of retention periods to PEG-J tubes between the two groups. In this study, 65% of AEs requiring tube replacement occurred within one year. However, the time of occurrence of AEs requiring tube replacement varied (Supplementary Table 2). Considering that the general PEG-J tube for enteral nutrition (non-LCIG PEG-J tube) is replaced every 6 months, the average duration of replacement in patients with tube replacement due to AEs was approximately 10 months, and 65% of AEs requiring replacement occurred within one year. Hence, the need for replacing the LCIG PEG-J tube may be necessary in the first year. Additionally, the PEG-J tube should be checked every 6 months for patency, residue adhesion, among others, for the early detection of AEs.
In this study, we also observed many tube-related AEs, but most of them could be treated with simple procedures or endoscopic tube replacement. No serious AEs caused by long-term tube placement were observed in this study. Most of the AEs could be managed with tube replacement. If patients are given enough information, they may choose to replace the tube when AEs requiring tube replacement occur, without periodic tube replacement.
At present, the timing of tube replacement should be handled flexibly depending on the situation of each facility or patient. In Japan, new tubes that can be easily replaced are now available. Further research with a long-term observation period is desirable.