Background and Aims
Post endoscopic submucosal dissection coagulation syndrome (PECS) occasionally occurs
after colorectal endoscopic submucosal dissection (ESD), presenting with localized
abdominal pain and inflammation. We conducted a randomized controlled trial (RCT)
to assess the usefulness of endoscopic clipping closure to prevent PECS and delayed
perforation (DP).
Methods
This is a multicenter, single-blind RCT. Prospectively enrolled patients undergoing
colorectal ESD were randomly allocated to endoscopic clipping closure and nonclosure
after ESD, stratifying by institution and tumor size. All participants underwent a
computed tomography scan after ESD. PECS was defined as visual analog scale (VAS) ≥30 mm,
an increase in VAS ≥20 mm from baseline, body temperature ≥37.5°C or white blood cells ≥10,000/μL
after colorectal ESD. DP was defined as PECS accompanied by extraluminal air. The
preplanned sample size was 320 patients, and the primary endpoint was the rate of
PECS/DP.
Results
At the planned interim analysis, this trial was terminated by recommendation of the
independent data and safety monitoring committee because conditional power with superiority
was lower than the preplanned futility limit. Finally, 155 patients were analyzed.
The rate of PECS/DP was 16% (95% confidence interval [CI], 8%-23%) in the nonclosure
group and 24% (95% CI, 14%-34%) in the closure group (P = .184). All cases of DP were within minor criteria, and all PECS/DP patients were
managed conservatively without surgical treatment. Simple periluminal air without
PECS was observed in 16% (95% CI, 8%-23%) in the nonclosure group and 10% (95% CI,
3%-17%) in the closure group.
Conclusion
Endoscopic clipping closure could not reduce the high incidence of PECS/DP after colorectal
ESD. (University Hospital Medical Network Clinical Trials Registry number: UMIN000027031.)
Abbreviations:
CI (confidence interval), DP (delayed perforation), ESD (endoscopic submucosal dissection), PECS (post-ESD coagulation syndrome), PPCS (post-polypectomy coagulation syndrome), RCT (randomized controlled trial), VAS (visual analog scale), WBC (white blood cells)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 27, 2019
Accepted:
November 19,
2019
Received:
August 14,
2019
Footnotes
DISCLOSURE: All authors disclosed no financial relationships.
Identification
Copyright
© 2020 by the American Society for Gastrointestinal Endoscopy
