PMID- 32878758
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 10
IP  - 9
DP  - 2020 Sep 2
TI  - Protocol of a randomised controlled phase II clinical trial investigating 
      PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi 
      to reduce postoperative pancreatic fistula after distal pancreatectomy: the 
      PREBOTPilot trial.
PG  - e036815
LID - 10.1136/bmjopen-2020-036815 [doi]
LID - e036815
AB  - INTRODUCTION: Postoperative pancreatic fistula (POPF) is still the most 
      frequently occurring and clinically relevant complication after distal 
      pancreatectomy (DP). Preoperative endoscopic injection of botulinum toxin (BTX) 
      into the sphincter of Oddi represents an innovative approach to prevent POPF. The 
      aim of this project (PREBOTPilot) is to generate the first randomised controlled 
      trial data on the safety, feasibility and efficacy of preoperative endoscopic BTX 
      injection into the sphincter of Oddi to prevent clinically relevant POPF 
      following DP. METHODS AND ANALYSIS: PREBOTPilot is an investigator-initiated, 
      single-centre, randomised, controlled, open-label, phase II clinical trial with 
      two parallel study groups and an exploratory study design. 60 patients scheduled 
      for DP will be randomised to intervention and control group. In the intervention 
      group, patients will undergo preoperative endoscopic injection of BTX into the 
      sphincter of Oddi, whereas in the control group no preoperative endoscopy will be 
      performed. The combined primary endpoint is the occurrence of clinically relevant 
      POPF and/or death within 30 days after DP. The secondary endpoints comprise 
      further postoperative outcome parameters and quality of life up to 3 months after 
      DP as well as safety and feasibility of the procedure. Statistical analysis is 
      based on the modified intention-to-treat population, excluding patients without 
      status post DP. For safety analysis, rates of adverse events (AEs) and serious 
      AEs will be calculated with 95% CIs for group comparisons. ETHICS, FUNDING AND 
      DISSEMINATION: PREBOTPilot has been approved by the German Federal Institute for 
      Drugs and Medical Devices (reference number 4043654) and the Ethics Committee of 
      Heidelberg University (reference number AFmo-523/2019). This trial is supported 
      by the German Federal Ministry of Education and Research (BMBF). The results of 
      the trial will be presented at national and international conferences and 
      published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: DRKS00020401.
CI  - (c) Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Klaiber, Ulla
AU  - Klaiber U
AUID- ORCID: 0000-0002-9287-1174
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Sauer, Peter
AU  - Sauer P
AD  - Interdisciplinary Centre of Endoscopy, University of Heidelberg, Heidelberg, 
      Baden-Wurttemberg, Germany.
FAU - Martin, Eike
AU  - Martin E
AD  - Patient Advocacy, University of Heidelberg, Heidelberg, Baden-Wurttemberg, 
      Germany.
FAU - Bruckner, Thomas
AU  - Bruckner T
AD  - Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, 
      Heidelberg, Baden-Wurttemberg, Germany.
FAU - Luntz, Steffen
AU  - Luntz S
AD  - Coordination Centre for Clinical Trials (KKS), University of Heidelberg, 
      Heidelberg, Baden-Wurttemberg, Germany.
FAU - Tjaden, Christine
AU  - Tjaden C
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Probst, Pascal
AU  - Probst P
AUID- ORCID: 0000-0002-0895-4015
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Knebel, Phillip
AU  - Knebel P
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Diener, Markus K
AU  - Diener MK
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Buchler, Markus W
AU  - Buchler MW
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany.
FAU - Hackert, Thilo
AU  - Hackert T
AD  - Department of General, Visceral and Transplantation Surgery, University of 
      Heidelberg, Heidelberg, Baden-Wurttemberg, Germany 
      thilo_hackert@med.uni-heidelberg.de.
LA  - eng
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200902
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - EC 3.4.24.69 (Botulinum Toxins)
SB  - IM
MH  - *Botulinum Toxins
MH  - Clinical Trials, Phase II as Topic
MH  - Endoscopy
MH  - Humans
MH  - Pancreatectomy/adverse effects
MH  - Pancreatic Fistula
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - *Sphincter of Oddi
PMC - PMC7470495
OTO - NOTNLM
OT  - gastroenterology
OT  - pancreatic disease
OT  - pancreatic surgery
COIS- Competing interests: None declared.
EDAT- 2020/09/04 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/09/02
CRDT- 2020/09/04 06:00
PHST- 2020/09/04 06:00 [entrez]
PHST- 2020/09/04 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/09/02 00:00 [pmc-release]
AID - bmjopen-2020-036815 [pii]
AID - 10.1136/bmjopen-2020-036815 [doi]
PST - epublish
SO  - BMJ Open. 2020 Sep 2;10(9):e036815. doi: 10.1136/bmjopen-2020-036815.