PMID- 28296471
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20231112
IS  - 1931-8405 (Electronic)
IS  - 0889-2229 (Print)
IS  - 0889-2229 (Linking)
VI  - 33
IP  - 8
DP  - 2017 Aug
TI  - The Safety of Multiple Flexible Sigmoidoscopies with Mucosal Biopsies in Healthy 
      Clinical Trial Participants.
PG  - 820-826
LID - 10.1089/aid.2016.0293 [doi]
AB  - During Phase 1 pharmacokinetic/pharmacodynamics studies, participants may undergo 
      multiple sigmoidoscopies, with a collection of 10-20 biopsies during each 
      procedure. This article characterizes the safety of flexible sigmoidoscopies in 
      clinical trial participants. We determined the number of flexible sigmoidoscopies 
      and rectal biopsies that participants underwent and analyzed the frequency, 
      duration, and severity of flexible sigmoidoscopy-related adverse events (AEs). 
      During the study period, 278 participants underwent 1,004 flexible 
      sigmoidoscopies with the collection of 15,930 rectal biopsies. The average number 
      of procedures per participant was 3.6 (median 3; range 1-25), with an average 
      time interval between procedures of 61.8 days (median 28 days; range 1-1,159). 
      There were no serious AEs. Sixteen AEs were related to flexible sigmoidoscopy and 
      occurred in 16 participants, leading to an overall 1.6% (16/1,004) AE rate per 
      procedure and 0.1% (16/15,930) AE rate per biopsy. Of the 16 AEs, 8 (50%) 
      involved abdominal pain, diarrhea, bleeding, flatulence, and bloating, with an 
      average duration of 4.7 days (median 1 day; range 1-28). Most (14/16) AEs were 
      categorized as Grade 1 (mild), whereas two of the AEs were Grade 2 (moderate). No 
      participant withdrew due to procedure-related AEs. Overall, the number of AEs 
      caused by flexible sigmoidoscopy with multiple biopsies was low and the severity 
      was mild, suggesting that this procedure can be safely integrated into protocols 
      requiring repeated intestinal mucosal sampling.
FAU - Chiu, Wai Kan
AU  - Chiu WK
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Brand, Rhonda M
AU  - Brand RM
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
AD  - 2 Department of Dermatology, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Camp, Danielle
AU  - Camp D
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
FAU - Edick, Stacey
AU  - Edick S
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
FAU - Mitchell, Carol
AU  - Mitchell C
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
FAU - Karas, Sherri
AU  - Karas S
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
FAU - Zehmisch, Amanda
AU  - Zehmisch A
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
FAU - Ho, Ken
AU  - Ho K
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Brand, Randall E
AU  - Brand RE
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Harrison, Janet
AU  - Harrison J
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Abo, Steven
AU  - Abo S
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - Cranston, Ross D
AU  - Cranston RD
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
FAU - McGowan, Ian
AU  - McGowan I
AD  - 1 Department of Medicine, University of Pittsburgh School of Medicine , 
      Pittsburgh, Pennsylvania.
AD  - 3 Magee-Women's Research Institute , Pittsburgh, Pennsylvania.
LA  - eng
GR  - U01 AI066734/AI/NIAID NIH HHS/United States
GR  - U19 AI060614/AI/NIAID NIH HHS/United States
GR  - UM1 AI068633/AI/NIAID NIH HHS/United States
GR  - U19 AI082637/AI/NIAID NIH HHS/United States
GR  - U01 AI046747/AI/NIAID NIH HHS/United States
GR  - UL1 TR000005/TR/NCATS NIH HHS/United States
GR  - UM1 AI069494/AI/NIAID NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20170315
PL  - United States
TA  - AIDS Res Hum Retroviruses
JT  - AIDS research and human retroviruses
JID - 8709376
SB  - IM
MH  - Adult
MH  - Biopsy/*adverse effects
MH  - *Clinical Trials as Topic
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Sigmoidoscopy/*adverse effects
MH  - Young Adult
PMC - PMC5564058
OTO - NOTNLM
OT  - adverse events
OT  - clinical trials
OT  - endoscopy
OT  - intestinal biopsy
COIS- No competing financial interests exist.
EDAT- 2017/03/16 06:00
MHDA- 2018/04/18 06:00
PMCR- 2018/08/01
CRDT- 2017/03/16 06:00
PHST- 2017/03/16 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/03/16 06:00 [entrez]
PHST- 2018/08/01 00:00 [pmc-release]
AID - 10.1089/aid.2016.0293 [pii]
AID - 10.1089/aid.2016.0293 [doi]
PST - ppublish
SO  - AIDS Res Hum Retroviruses. 2017 Aug;33(8):820-826. doi: 10.1089/aid.2016.0293. 
      Epub 2017 Mar 15.