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
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....
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e036815.full |
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| author | Phillip Knebel Thilo Hackert Markus W Büchler Thomas Bruckner Peter Sauer Markus K Diener Christine Tjaden Ulla Klaiber Pascal Probst Eike Martin Steffen Luntz |
| author_facet | Phillip Knebel Thilo Hackert Markus W Büchler Thomas Bruckner Peter Sauer Markus K Diener Christine Tjaden Ulla Klaiber Pascal Probst Eike Martin Steffen Luntz |
| author_sort | Phillip Knebel |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-64672ce0743b419388bddf12cb989964 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-64672ce0743b419388bddf12cb9899642025-01-08T16:00:08ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2020-036815Protocol 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 trialPhillip Knebel0Thilo Hackert1Markus W Büchler2Thomas Bruckner3Peter Sauer4Markus K Diener5Christine Tjaden6Ulla Klaiber7Pascal Probst8Eike Martin9Steffen Luntz10Department of General, Visceral and Transplantation Surgery, Heidelberg University, Heidelberg, GermanyDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, GermanyDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany4 Institute of Medical Biometry and Informatics (IMBI), University of Heidelberg, Heidelberg, Baden-Württemberg, Germany1 Department of Internal Medicine IV, University Hospital of Heidelberg, Heidelberg, GermanyDepartment of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, GermanyDepartment of General, Visceral and Transplantation Surgery, Universitätsklinikum Heidelberg, Heidelberg, GermanyDepartment of General, Visceral and Transplantation Surgery, Universitätsklinikum Heidelberg, Heidelberg, Germany1 Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Baden-Württemberg, GermanyPatient Advocacy, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany5 Coordination Centre for Clinical Trials (KKS), University of Heidelberg, Heidelberg, Baden-Württemberg, GermanyIntroduction 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.https://bmjopen.bmj.com/content/10/9/e036815.full |
| spellingShingle | Phillip Knebel Thilo Hackert Markus W Büchler Thomas Bruckner Peter Sauer Markus K Diener Christine Tjaden Ulla Klaiber Pascal Probst Eike Martin Steffen Luntz 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/9/e036815.full |
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