A Single-arm Phase II Trial of Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Phase: PHASE2
Conditions: Pancreas Cancer, Pancreas Disease, Pancreas Adenocarcinoma, Pancreas; Fistula, Surgery, Surgery--Complications, Surgery Site Fistula
Sponsor: Sunnybrook Health Sciences Centre

 
 
CONFIDENTIAL 
 
1 
PATCH-DP Protocol: Version 2.0 18-APR-2018 
PROTOCOL SUMMARY 
Protocol Title (Short 
Title) 
PATCH - DP 
Protocol Number 
346-2017 
Phase 
II 
Study Design 
Multicentre, single-arm, phase II clinical trial  
Study Duration 
1 year 
Setting 
Multicentre  
Sample Size 
52 patients  
Main Inclusion 
Criteria 
Adults >18 years of age undergoing distal pancreatectomy +/- 
splenectomy for any indication 
Primary Outcome: 
Post-operative pancreatic fistula (ISGPF Grade B/C) 
Secondary Outcomes: 
Post-operative pancreatic fistula (all grades), Mortality, 
Readmissions, Re-interventions, Post-operative complications 
Investigational 
Product and Planned 
Use 
HEMOPATCH flexible hemostat applied intraoperatively to the 
pancreatic stump following distal pancreatectomy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
 
2 
PATCH-DP Protocol: Version 2.0 18-APR-2018 
STATISTICAL CONSIDERATIONS 
Study Hypothesis 
 
We hypothesize that application of the HEMOPATCH pad to the pancreatic stump following DP 
will decrease the incidence of clinically significant (ISGPF Grade B/C) post-operative pancreatic 
fistulas. 
Sample Size Considerations 
 
Operative application of HEMOPATCH will be considered effective at reducing the rate of POPF 
if there is a 50% relative reduction in the incidence of Grade B/C POPF. Assuming a baseline 
Grade B/C POPF rate of 20%, in order to detect an absolute reduction of 10% with power of 
0.80 and alpha of 0.05, a total sample size of 398 patients would be required for a definitive 
phase III trial. 
 
For this trial, we used a one-sample test for proportion. The null hypothesis that the true rate 
of Grade B/C POPF is 20% will be tested against the alternative hypothesis of a 10% rate of 
POPF in patients undergoing application of HEMOPATCH. A total of 52 patients in the study 
group is required, assuming a type I error rate of 0.20 and a power of 0.75 (a priori thresholds 
for proceeding to a definitive phase 3 randomized trial) when the true rate of Grade B/C POPF 
is 10% in the study group. 
Stopping Rules 
 
This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse events that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; (3) 
any new information becomes available during the trial that necessitates stopping the trial; or 
(4) other situations occur that might warrant stopping the trial. 
Analysis Plan 
 
Descriptive statistics will be used to examine the baseline characteristics of included and 
excluded participants. Mean and standard deviations will be reported for all characteristics 
expressed as continuous variables. Medians and ranges will be presented for discrete data.  
 
The primary outcome is incidence of Grade B/C POPF. Comparison of incidence of Grade B/C 
POPF in the study population will be made to the baseline rate of 20% by unadjusted one-
sample test for proportion. Rates of all secondary outcomes will be calculated along with 95% 
confidence intervals.