Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F25%3A00085549" target="_blank" >RIV/00023001:_____/25:00085549 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11110/25:10496390 RIV/00064203:_____/25:10496390
Výsledek na webu
<a href="https://www.sciencedirect.com/science/article/abs/pii/S2468125325000123?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/abs/pii/S2468125325000123?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S2468-1253(25)00012-3" target="_blank" >10.1016/S2468-1253(25)00012-3</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial
Popis výsledku v původním jazyce
Background: In this trial, we previously showed per-oral endoscopic myotomy (POEM) to be non-inferior to laparoscopic Heller's myotomy (LHM) plus Dor fundoplication in managing symptoms in patients with idiopathic achalasia 2 years post-procedure. However, post-procedural gastro-oesophageal reflux was more common after POEM at 2 years. Here we report 5-year follow-up data. Methods: This study is a multicentre, randomised, open-label, non-inferiority trial performed at eight centres in six European countries (Germany, Italy, Czech Republic, Sweden, the Netherlands, and Belgium). Patients with symptomatic primary achalasia were eligible for inclusion if they were older than 18 years and had an Eckardt symptom score higher than 3. Patients were randomly assigned (1:1; randomly permuted blocks of sizes 4, 8, or 12) to undergo either POEM or LHM plus Dor fundoplication. The primary endpoint was clinical success, defined by an Eckardt symptom score of 3 or less without the use of additional treatments, at 2 years, and was reported previously. Prespecified secondary endpoints at 5 years were clinical success; Eckardt symptom score; Gastrointestinal Quality of Life Index score; lower oesophageal sphincter function by high-resolution manometry; and parameters of post-procedural reflux (reflux oesophagitis according to the Los Angeles classification; pH-metry, and DeMeester clinical score). We hypothesised that POEM would be non-inferior (with a non-inferiority margin of -12<middle dot>5 percentage points) to LHM plus Dor fundoplication with regards to clinical success. All analyses were performed on a modified intention-to-treat (mITT) population, which included all patients who underwent the assigned procedure. This study is registered with ClinicalTrials.gov (NCT01601678) and is complete. Findings: Between Dec 7, 2012, and Oct 9, 2015, 241 patients were randomly assigned (120 to POEM and 121 to LHM) and 221 had the assigned treatment (112 POEM and 109 LHM; mITT). 5-year follow up data were available for 90 (80%) patients in the POEM group and 87 (80%) patients in the LHM group. Clinical success rate at 5 years was 75<middle dot>0% (95% CI 66<middle dot>2 to 82<middle dot>1) after POEM and 70<middle dot>8% (61<middle dot>7 to 78<middle dot>5) after LHM (difference 4<middle dot>2 percentage points [95% CI -7<middle dot>4 to 15<middle dot>7]). The mean Eckardt symptom score decreased from baseline to 5 years in both groups and the overall difference in mean scores was -0<middle dot>29 (95% CI -0<middle dot>62 to 0<middle dot>05). Change in Gastrointestinal Quality of Life Index scores, as well as in integrated relaxation pressure on manometry, from baseline to 5 years, did not differ significantly between the groups. At 5 years, 26 (41%) of 63 patients after POEM and 18 (31%) of 58 patients after LHM had reflux oesophagitis (difference 10<middle dot>2 percentage points [95% CI -7<middle dot>0 to 26<middle dot>8]). Significant oesophagitis (Los Angeles classification grade B, C, or D) was observed in nine (14%) of 63 patients after POEM and in four (7%) of 58 patients after LHM. pH-metry was performed in 81 (37%) of 221 patients, with higher mean acid exposure time for POEM (10<middle dot>2% [95% CI 7<middle dot>6 to 14<middle dot>2]) than for LHM (5<middle dot>5% [3<middle dot>1 to 11<middle dot>8]). Significantly more patients in the POEM than in the LHM group had abnormal acid exposure time at 5 years (>4<middle dot>5%; 28 [62%] of 45 vs 11 [31%] of 36; difference 31<middle dot>7 percentage points [95% CI 9<middle dot>8 to 50<middle dot>5]). The presence of reflux symptoms at 5 years was similar in both groups, with a mean DeMeester clinical score of 1<middle dot>3 (95% CI 1<middle dot>0 to 1<middle dot>6) after POEM and 1<middle dot>1 (0<middle dot>9 to 1<middle dot>4) after LHM. The complications of peptic stricture, Barrett's oesophagus, and oesophageal adenocarcinoma were not reported. Interpretation: Our long-term results support the role of POEM as a less invasive myotomy approach that is non-inferior to LHM in controlling symptoms of achalasia. Gastro-oesophageal reflux was common in both groups, but with a tendency towards higher rates in the POEM group. Thus, patients should be provided with the advantages and disadvantages of each approach in decision making.
Název v anglickém jazyce
Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial
Popis výsledku anglicky
Background: In this trial, we previously showed per-oral endoscopic myotomy (POEM) to be non-inferior to laparoscopic Heller's myotomy (LHM) plus Dor fundoplication in managing symptoms in patients with idiopathic achalasia 2 years post-procedure. However, post-procedural gastro-oesophageal reflux was more common after POEM at 2 years. Here we report 5-year follow-up data. Methods: This study is a multicentre, randomised, open-label, non-inferiority trial performed at eight centres in six European countries (Germany, Italy, Czech Republic, Sweden, the Netherlands, and Belgium). Patients with symptomatic primary achalasia were eligible for inclusion if they were older than 18 years and had an Eckardt symptom score higher than 3. Patients were randomly assigned (1:1; randomly permuted blocks of sizes 4, 8, or 12) to undergo either POEM or LHM plus Dor fundoplication. The primary endpoint was clinical success, defined by an Eckardt symptom score of 3 or less without the use of additional treatments, at 2 years, and was reported previously. Prespecified secondary endpoints at 5 years were clinical success; Eckardt symptom score; Gastrointestinal Quality of Life Index score; lower oesophageal sphincter function by high-resolution manometry; and parameters of post-procedural reflux (reflux oesophagitis according to the Los Angeles classification; pH-metry, and DeMeester clinical score). We hypothesised that POEM would be non-inferior (with a non-inferiority margin of -12<middle dot>5 percentage points) to LHM plus Dor fundoplication with regards to clinical success. All analyses were performed on a modified intention-to-treat (mITT) population, which included all patients who underwent the assigned procedure. This study is registered with ClinicalTrials.gov (NCT01601678) and is complete. Findings: Between Dec 7, 2012, and Oct 9, 2015, 241 patients were randomly assigned (120 to POEM and 121 to LHM) and 221 had the assigned treatment (112 POEM and 109 LHM; mITT). 5-year follow up data were available for 90 (80%) patients in the POEM group and 87 (80%) patients in the LHM group. Clinical success rate at 5 years was 75<middle dot>0% (95% CI 66<middle dot>2 to 82<middle dot>1) after POEM and 70<middle dot>8% (61<middle dot>7 to 78<middle dot>5) after LHM (difference 4<middle dot>2 percentage points [95% CI -7<middle dot>4 to 15<middle dot>7]). The mean Eckardt symptom score decreased from baseline to 5 years in both groups and the overall difference in mean scores was -0<middle dot>29 (95% CI -0<middle dot>62 to 0<middle dot>05). Change in Gastrointestinal Quality of Life Index scores, as well as in integrated relaxation pressure on manometry, from baseline to 5 years, did not differ significantly between the groups. At 5 years, 26 (41%) of 63 patients after POEM and 18 (31%) of 58 patients after LHM had reflux oesophagitis (difference 10<middle dot>2 percentage points [95% CI -7<middle dot>0 to 26<middle dot>8]). Significant oesophagitis (Los Angeles classification grade B, C, or D) was observed in nine (14%) of 63 patients after POEM and in four (7%) of 58 patients after LHM. pH-metry was performed in 81 (37%) of 221 patients, with higher mean acid exposure time for POEM (10<middle dot>2% [95% CI 7<middle dot>6 to 14<middle dot>2]) than for LHM (5<middle dot>5% [3<middle dot>1 to 11<middle dot>8]). Significantly more patients in the POEM than in the LHM group had abnormal acid exposure time at 5 years (>4<middle dot>5%; 28 [62%] of 45 vs 11 [31%] of 36; difference 31<middle dot>7 percentage points [95% CI 9<middle dot>8 to 50<middle dot>5]). The presence of reflux symptoms at 5 years was similar in both groups, with a mean DeMeester clinical score of 1<middle dot>3 (95% CI 1<middle dot>0 to 1<middle dot>6) after POEM and 1<middle dot>1 (0<middle dot>9 to 1<middle dot>4) after LHM. The complications of peptic stricture, Barrett's oesophagus, and oesophageal adenocarcinoma were not reported. Interpretation: Our long-term results support the role of POEM as a less invasive myotomy approach that is non-inferior to LHM in controlling symptoms of achalasia. Gastro-oesophageal reflux was common in both groups, but with a tendency towards higher rates in the POEM group. Thus, patients should be provided with the advantages and disadvantages of each approach in decision making.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30219 - Gastroenterology and hepatology
Návaznosti výsledku
Projekt
—
Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2025
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Lancet gastroenterology and hepatology [online]
ISSN
2468-1253
e-ISSN
2468-1253
Svazek periodika
10
Číslo periodika v rámci svazku
5
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
11
Strana od-do
431-441
Kód UT WoS článku
001469410800001
EID výsledku v databázi Scopus
2-s2.0-105000346880