PMID- 33492500
OWN - NLM
STAT- MEDLINE
DCOM- 20220301
LR  - 20220301
IS  - 1432-2218 (Electronic)
IS  - 0930-2794 (Linking)
VI  - 36
IP  - 1
DP  - 2022 Jan
TI  - Efficacy of oral steroid gel in preventing esophageal stricture after extensive 
      endoscopic submucosal dissection: a randomized controlled trial.
PG  - 402-412
LID - 10.1007/s00464-021-08296-2 [doi]
AB  - BACKGROUND AND AIMS: Esophageal stricture is a distressing issue for patients 
      with early esophageal cancer following extensive endoscopic submucosal dissection 
      (ESD), and the current steroid-based approaches are unsatisfactory for stricture 
      prophylaxis. We evaluated the efficacy of oral hydrocortisone sodium succinate 
      and aluminum phosphate gel (OHA) for stricture prophylaxis after extensive ESD. 
      METHODS: Patients undergoing > 3/4 circumferential ESD were randomized to either 
      the endoscopic loco-regional triamcinolone acetonide injection (ETI) plus oral 
      prednisone group or the OHA group. The primary endpoint was incidence of 
      esophageal stricture, and the secondary endpoints included adverse events (AEs) 
      and endoscopic balloon dilations (EBDs). RESULTS: The incidence of esophageal 
      stricture in OHA group (per-protocol analysis, 9.4%, 3/32; intention-to-treat 
      analysis, 12.1%, 4/33) was significantly less than that of control group 
      (per-protocol analysis, 35.5%, 11/31, P = 0.013; intention-to-treat analysis, 
      39.4%, 13/33, P = 0.011). Two sessions of EBD were necessary to release all 
      strictures in the OHA group, while the similar EBDs (median 2, range 1-4) for 11 
      of the control. Operation-related AEs included infection (control vs. OHA 
      group = 9.7% vs. 31.3%, P = 0.034), operation-related hypokalemia (19.4% vs. 
      31.3%, P = 0.278), perforation (3.2% vs. 3.1%), post-ESD hemorrhage (6.5% vs. 
      0%), and cardiac arrhythmia (0% vs. 6.3%). Steroid-related AEs included 
      steroid-related hypokalemia (16.1% vs. 25%) and bone fracture (3.2% vs. 0%). 
      Multivariate logistic regression analysis demonstrated that OHA was an 
      independent protective factor for stricture (OR 0.079; 95%CI 0.011, 0.544; 
      P = 0.01) and mucosal defect > 11/12 circumference was an independent risk factor 
      (OR 49.91; 95%CI 6.7, 371.83; P < 0.001). CONCLUSIONS: OHA showed significantly 
      better efficacy in preventing esophageal stricture after > 3/4 circumferential 
      ESD compared to ETI plus oral prednisone.
CI  - (c) 2021. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC part of Springer Nature.
FAU - Zhang, Yiyang
AU  - Zhang Y
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Yan, Xiue
AU  - Yan X
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Huang, Yonghui
AU  - Huang Y
AUID- ORCID: 0000-0002-0238-746X
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China. 13911765322@163.com.
FAU - Nie, Dan
AU  - Nie D
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Wang, Yingchun
AU  - Wang Y
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Chang, Hong
AU  - Chang H
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Zhang, Yaopeng
AU  - Zhang Y
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Yao, Wei
AU  - Yao W
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
FAU - Li, Ke
AU  - Li K
AD  - The Department of Gastroenterology, Peking University Third Hospital, 49 North 
      Garden Rd., Haidian District, Beijing, China.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210125
PL  - Germany
TA  - Surg Endosc
JT  - Surgical endoscopy
JID - 8806653
RN  - 0 (Steroids)
RN  - 1ZK20VI6TY (Triamcinolone)
SB  - IM
MH  - *Endoscopic Mucosal Resection/adverse effects
MH  - *Esophageal Neoplasms/complications
MH  - *Esophageal Stenosis/etiology/prevention & control
MH  - Humans
MH  - Steroids
MH  - Triamcinolone
OTO - NOTNLM
OT  - Early esophageal cancer
OT  - Endoscopic submucosal dissection
OT  - Esophageal stricture
OT  - Steroid
EDAT- 2021/01/26 06:00
MHDA- 2022/03/03 06:00
CRDT- 2021/01/25 12:16
PHST- 2020/08/07 00:00 [received]
PHST- 2021/01/05 00:00 [accepted]
PHST- 2021/01/26 06:00 [pubmed]
PHST- 2022/03/03 06:00 [medline]
PHST- 2021/01/25 12:16 [entrez]
AID - 10.1007/s00464-021-08296-2 [pii]
AID - 10.1007/s00464-021-08296-2 [doi]
PST - ppublish
SO  - Surg Endosc. 2022 Jan;36(1):402-412. doi: 10.1007/s00464-021-08296-2. Epub 2021 
      Jan 25.