PMID- 33849942
OWN - NLM
STAT- MEDLINE
DCOM- 20220509
LR  - 20220509
IS  - 1468-3288 (Electronic)
IS  - 0017-5749 (Print)
IS  - 0017-5749 (Linking)
VI  - 71
IP  - 4
DP  - 2022 Apr
TI  - Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: 
      results from a randomised, sham controlled trial.
PG  - 686-694
LID - 10.1136/gutjnl-2020-321811 [doi]
AB  - BACKGROUND: The majority of endoscopic antireflux procedures for GERD are 
      cumbersome to use and randomised long-term data are sparse. We conducted such a 
      trial to determine the efficacy and safety of a novel, easy to use endoscopic 
      full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN: 
      Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to 
      either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was >/=50% 
      improvement in the health-related quality of life (GERD-HRQL) score at 3 months. 
      Secondary end points included improvement in GERD-HRQL, reflux symptom scores, 
      PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings 
      at 3, 6 and 12 months. RESULTS: Seventy patients were randomised; 35 in each 
      group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had 
      non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 
      (+/-19.93). The mean (+/-SD) duration of EFTP procedure was 17.4 (+/-4) min. The 
      primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; 
      p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the 
      EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 
      (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% 
      patients were off-PPI at 12 months compared with 11.4% in the sham group 
      (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total 
      reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but 
      not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment 
      (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major 
      procedure-related adverse events were encountered in either group. CONCLUSION: 
      EFTP using a novel device is safe and effective in improving quality of life in 
      patients with PPI dependent mostly non-erosive reflux disease at short and long 
      terms; objective parameters showed a limited response rate. TRIAL REGISTRATION 
      NUMBER: NCT03322553.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Kalapala, Rakesh
AU  - Kalapala R
AUID- ORCID: 0000-0003-3203-7708
AD  - Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 
      Telangana, India drkalpala@gmail.com.
FAU - Karyampudi, Arun
AU  - Karyampudi A
AD  - Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 
      Telangana, India.
FAU - Nabi, Zaheer
AU  - Nabi Z
AD  - Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, 
      Telangana, India.
FAU - Darisetty, Santosh
AU  - Darisetty S
AD  - Anaesthesia, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.
FAU - Jagtap, Nitin
AU  - Jagtap N
AUID- ORCID: 0000-0002-3469-0164
AD  - Medical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.
FAU - Ramchandani, Mohan
AU  - Ramchandani M
AD  - Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, 
      India.
FAU - Gupta, Rajesh
AU  - Gupta R
AD  - Asian Institute of Gatroenterology, Hyderabad, India.
FAU - Lakhtakia, Sundeep
AU  - Lakhtakia S
AD  - Gastroenterology, Asian Institute of Gastroenetrology, Hyderabad, Andhra Pradesh, 
      India.
FAU - Goud, Rajesh
AU  - Goud R
AD  - Asian Institute of Gastroenterology, Hyderabad, Telangana, India.
FAU - Venkat Rao, G
AU  - Venkat Rao G
AD  - Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India.
FAU - Sharma, Prateek
AU  - Sharma P
AD  - University of Kansas, Kansas City, Kansas, USA.
FAU - Reddy, D Nageshwar
AU  - Reddy DN
AD  - Asian Healthcare Foundation, Asian Institute of Gastroenterology, Hyderabad, 
      Andhra Pradesh, India.
LA  - eng
SI  - ClinicalTrials.gov/NCT03322553
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210413
PL  - England
TA  - Gut
JT  - Gut
JID - 2985108R
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Adult
MH  - Endoscopy, Gastrointestinal
MH  - *Esophagitis, Peptic
MH  - Female
MH  - *Gastroesophageal Reflux/complications/surgery
MH  - Humans
MH  - Male
MH  - Proton Pump Inhibitors/therapeutic use
MH  - Quality of Life
MH  - Treatment Outcome
PMC - PMC8921577
OTO - NOTNLM
OT  - endoscopy
OT  - gastroesophageal reflux disease
OT  - quality of life
COIS- Competing interests: None declared.
EDAT- 2021/04/15 06:00
MHDA- 2022/05/10 06:00
PMCR- 2022/03/15
CRDT- 2021/04/14 05:52
PHST- 2020/05/13 00:00 [received]
PHST- 2021/03/30 00:00 [revised]
PHST- 2021/04/01 00:00 [accepted]
PHST- 2021/04/15 06:00 [pubmed]
PHST- 2022/05/10 06:00 [medline]
PHST- 2021/04/14 05:52 [entrez]
PHST- 2022/03/15 00:00 [pmc-release]
AID - gutjnl-2020-321811 [pii]
AID - 10.1136/gutjnl-2020-321811 [doi]
PST - ppublish
SO  - Gut. 2022 Apr;71(4):686-694. doi: 10.1136/gutjnl-2020-321811. Epub 2021 Apr 13.