INTRODUCTION:
We investigated to compare the effect of empirical therapy
vs
clarithromycin resistance–guided tailored therapy (tailored therapy) for eradication of
Helicobacter pylori
.
METHODS:
In this prospective, single center, open-label randomized controlled trial, we enrolled 72 patients with
H. pylori
infection from January 2019 through June 2019 in Korea. The patients were randomly assigned to both groups received empirical (n = 36) or tailored therapy (n = 36). Empirical therapy was defined as triple therapy with esomeprazole, amoxicillin, and clarithromycin for 10 days irrespective of clarithromycin resistance. Tailored therapy was triple or quadruple therapy with esomeprazole, metronidazole, tetracycline, and bismuth for 10 days based on genotype markers of resistance determined by gastric biopsy. Resistance-associated mutations in 23S rRNA were confirmed by multiplex polymerase chain reaction. Eradication status was assessed by
13
C-urea breath test, and the primary outcome was eradication rates.
RESULTS:
H
.
pylori
was eradicated in 27 patients (75.0%), given empirical therapy and 32 patients (88.9%) treated with tailored therapy (
P
= 0.136) in intention-to-treat analysis. In per protocol analysis, the eradication rate was 97.0% and 81.8% in tailored
vs
empirical groups (
P
= 0.046). Although clarithromycin-resistant
H. pylori
was eradicated in 3/9 (33.3%) with empirical therapy, it was treated in 11/12 (91.7%) with tailored therapy (
P
= 0.009). There was no difference in compliance between 2 groups. The rate of adverse events of the tailored group was higher than that of the empirical group (
P
= 0.036) because quadruple therapy had more side effects than those of triple therapy (
P
= 0.001).
DISCUSSION:
Tailored therapy based on polymerase chain reaction is a good alternative to increase eradication rates in a region of high prevalence of clarithromycin resistance (see Visual Abstract, Supplementary Digital Content 1,
http://links.lww.com/CTG/A342
).
Background/AimsCurrent guidelines recommend withholding antiplatelets for 5–7 days before high-risk endoscopic procedures. We investigated whether this reduces post-endoscopic submucosal dissection (ESD) bleeding.MethodsGastric ESD cases with antiplatelets were retorospectively reviewed. Withholding antiplatelets for 5–7 days before ESD was defined as cessation and 0–4 days as continuation. The rate and risk of post-ESD bleeding according to the types and cessation of antiplatelets were assessed.ResultsAmong the 215 patients (117 adenoma and 98 early gastric cancer), 161 patients were on single (94 aspirin, 56 thienopyridine, and 11 other agents), 51 on dual, and 3 on triple antiplatelets. Post-ESD bleeding rates were 12.8% in aspirin users, 3.6% in thienopyridine, 27.5% in dual, 33.3% in triple therapy, and 9.7% in the cessation and 15.0% in the continuation group. Multiple antiplatelets (odds ratio [OR], 2.41; 95% confidence interval [CI], 1.01 to 5.76) and specimen size ≥ 5.5 cm (OR, 2.84; 95% CI, 1.04 to 7.73) were the risk of bleeding, while continuation of thienopyridine (OR, 0.23; 95% CI, 0.05 to 1.09) and antiplatelets (OR, 1.83; 95% CI, 0.68 to 4.94) did not increase the risk of bleeding.ConclusionsContinuing thienopyridine and aspirin did not increase the risk of post-ESD. Multiple antiplatelet therapy and a large specimen size were independent risk factors of post-ESD bleeding.
INTRODUCTION:
Endoscopic submucosal dissection (ESD) is a preferred treatment option for superficial esophageal squamous cell carcinoma (SESCC). However, only few studies compared long-term survival outcomes of ESD with surgery. This study compared the overall survival (OS), recurrence-free survival, and complication rates of ESD with those of surgery.
METHODS:
We reviewed patients who underwent ESD (n = 70) or surgery (n = 114) for SESCC at Seoul National University Hospital from 2011 to 2017. A propensity score-matched analysis was used to reduce selection bias. To increase the precision of our results interpretation, subgroups were analyzed according to the depth of tumor invasion.
RESULTS:
In the matching study, the ESD group (n = 34) showed comparable survival outcomes with the surgery group (n = 34). The 5-year OS rates were 89.4% vs 87.8% for the ESD and the surgery groups, respectively; similarly, the 5-year recurrence-free survival rates were 90.9% and 91.6%, respectively. The ESD group showed a lower early major complication rate (2.9% [1 of 34] vs 23.5% [8 of 34],
P
< 0.001) and shorter hospital stay (median, 3.0 days vs 16.5 days,
P
< 0.001) than the surgery group. In the tumor
in situ
(Tis)-subgroup, ESD showed better OS than esophagectomy (
P
= 0.030). Between-group comparisons of survival outcomes in the T1a and T1b subgroups revealed no significant differences.
DISCUSSION:
Long-term outcomes of ESD are comparable with surgery for patients with SESCC. For early major complications and duration of hospital stay, ESD was associated with better outcomes than radical surgery. These results support ESD as the preferred treatment option for SESCC.
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