Tisseel® as a Reinforcement of Esophagojejunal Anastomoses
Primary Purpose
Gastric Cancer, Anastomotic Leak
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Tisseel
No Tisseel
Sponsored by
About this trial
This is an interventional prevention trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients over 18 years diagnosed with gastric adenocarcinoma and scheduled for a total gastrectomy with curative intent in EURECCA Esophagogastric Cancer Group who agree to participate in the study and sign the informed consent
Exclusion Criteria:
- Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.
Sites / Locations
- Elisenda Garsot SavallRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Tisseel®
no Tisseel®
Arm Description
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis. The rest of the surgical procedure is as usual.
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm " noTisseel®" surgeon performs the surgical procedure as usual.
Outcomes
Primary Outcome Measures
Rate of esophagojejunal anastomotic leak in immediate postoperative period
Clinical or radiological (see anex 1: Score Goense) evidence of esophagojejunal anastomotic leak.
Secondary Outcome Measures
Amylases level in drainage
Amylase level (mg/L) in drainage
CRP (C-reactive protein) in blood
C-reactive protein in blood (mg/L)
Procalcitonin in blood
Procalcitonin in blood (mg/L)
White cell levels in blood
White cell levels in blood (x109/L)
Results of Computed Tomography with oral contrast.
The results will be expressed based on Goense Score
Based on Score Goense (Anastomotic Leakage Prediction Score). The investigator will collect the presence of:
Yes No Normal Fluid collection Air cavity Fistula Wall discontinuity Empiema
Goense L, Stassen PMC, Wessels FJ, van Rossum PSN, Ruurdal JP, van Leeuwen MS, van Hillegersberg R. Diagnostic performance of a CT-based scoring system for diagnosis of anastomotic leakage after esophagectomy: comparison with subjective CT assessment. Eur Radiol 2017; 27:4426-34
Type of esophagojejunal anastomoses performed
The type of esophagojejunal anastomoses performed can be:
mechanical (circular)
mechanical (lineal)
manual
Postoperative complications
Postoperative complications (Clavien-Dindo score):
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III Requiring surgical, endoscopic or radiological intervention
IIIa Intervention not under general anesthesia
IIIb Intervention under general anesthesia
Grade IV Life-threatening complication requiring IC/ICU-management
IVa single organ dysfunction (including dialysis)
IVb multiorgandysfunction
Grade V Death of a patient
90-day mortality
Mortality at 90 days after surgery
Need for urgent surgical re-intervention
Reintervention after surgery:
Yes/Not
Hospital stay
Number of days of hospital stay
Readmission
Readmission within 30 days after discharge:
Yes/Not
Full Information
NCT ID
NCT03733639
First Posted
October 18, 2018
Last Updated
July 21, 2020
Sponsor
Germans Trias i Pujol Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03733639
Brief Title
Tisseel® as a Reinforcement of Esophagojejunal Anastomoses
Official Title
The Use of Fibrin Glue Sealant (Tisseel®) as a Reinforcement of Esophagojejunal Anastomoses Will Decrease the Rate of Anastomotic Leak.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Germans Trias i Pujol Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background:
The dehiscence of esophagojejunal anastomoses is one of the most serious complications after total gastrectomy in patients with gastric cancer. Any method of avoiding this problem will affect not only the postoperative course but also the prognostic of disease.
Methods:
This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Group, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer. The rate of anastomosis leak will be measured with clinical, radiological and analytic parameters.
Objective:
Analyze the efficacy of Tisseel® as a reinforcement in reducing the rate of anastomotic esophagojejunal anastomoses.
Detailed Description
Introduction The dehiscence of the esophagojejunal anastomosis is one of the most serious complications after a total gastrectomy not only in the short term but it has been shown to be an independent risk factor for survival. The rate of esophagojejunal anastomosis leakage after cancer gastrectomies is described to be between 1-12.3%.
Any method to prevent this complication would be of vital importance to improve the evolution of these patients. Likewise, when the dehiscence has been established, early detection could contribute to an early intervention, avoiding more serious consequences and, therefore, improving the short and long term prognosis.
Little progress has been made during recent decades in the prevention of anastomotic leakage in high-risk digestive tract anastomosis. Some authors have tried the use of new methods of suture, reinforcements or patches in the anastomosis. Fibrin adhesives were introduced more than 30 years ago, in order to favor hemostasis and tissue adhesion. Numerous studies have demonstrated their effectiveness in reducing surgical bleeding in cardiovascular surgery but its role as a sealant in gastrointestinal anastomosis is more debated. There have been some experimental studies that have shown a possible protective effect of this material in enteric anastomoses. With the evolution of bariatric surgery and with the high volume of surgeries handled, several studies have been published that assess the effect of fibrin sealants on gastrojejunal anastomoses. In esophagogastric surgery, the number of published studies is reduced and there are only 2 studies that assess the effect of fibrin sealants on esophagojejunal anastomosis. The results of these studies seem to indicate that the application of fibrin sealants in this anastomosis could have a favorable effect in reducing the number of anastomotic dehiscences.
There are different definitions for the concept of "anastomotic dehiscence". The dehiscence of the esophago-jejunal anastomotic can be defined as any clinical and / or radiological evidence of dehiscence of the anastomosis. Although early diagnosis is key to avoiding major consequences, in clinical practice, the diagnosis of anastomotic dehiscence is often delayed. Direct observation of the debit of surgical drainage, fever or persistent ileus or clear symptoms of peritonitis are indirect signs that make us suspect a possible anastomotic dehiscence. The possibility of having a parameter that allows us to diagnose early a problem in the suture would allow us to act earlier and, therefore, improve the prognosis of these patients in the short and long term.
In colorectal surgery, serological parameters such as procalcitonin or C-reactive protein have been studied as early predictors of anastomotic dehiscence. In esophagogastric surgery, publications are scarce and all of them analyze results in esophagogastric anastomoses.
Furthermore, the determination of amylases in drainage has also been used for the detection of postoperative fistula. It is a simple and low cost method and is a parameter widely used in pancreatic surgery for the detection and evolutionary control of pancreatic fistulas. It has also been shown to be useful in esophageal surgery and in bariatric surgery. However, in gastric cancer it has only been used for the diagnosis of pancreatic fistula as a complication in total gastrectomies with associated splenectomy.
Finally, the use of radiology with oral contrast routinely in the postoperative period of esophagogastric surgery has been shown to have a low sensitivity for the early detection of anastomotic dehiscence. CT with oral contrast seems to have greater sensitivity and positive predictive value in esophageal surgery for this purpose, but the need to perform a postoperative test to evaluate the anastomosis without clinical evidence of dehiscence is unclear.
For all these reasons, we believe that a multicenter randomized study will contribute to improve the clinical results of esophagogastric surgery and the knowledge of the diagnosis of complications, by studying the efficacy of Tisseel® in reducing the rate of anastomotic leakage, but also analyzing the role of drain amylases, serum CRP (C-reactive protein), procalcitonin and white blood cell levels in the early detection and prediction of anastomotic leak, and the role of CT with oral contrast as a routine assessment of anastomotic integrity.
Objective Analyze the efficacy of Tisseel® in reducing the rate of anastomotic leakage diagnosed in the postoperative period using clinical and / or radiological parameters.
Methods This is a prospective, randomized and multicenter trial, within the Spanish EURECCA Esophagogastric Cancer Project, to investigate the efficacy of Tisseel® in reducing the rate of esophagojejunal anastomosis leakage in patients with gastric cancer.
Participation study will be offered to all centers that are currently part of the Spanish EURECCA Esophagogastric Cancer Group. Those hospitals that show their desire to participate must sign the Letter of Commitment. In the same way, the study must sign off by European Medicine Agency and Spanish Agency of Medicines.
Once the patient is included in the study the surgeon performs a total gastrectomy as usual procedure. Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). Surgeon dispenses Tisseel® all over the anastomosis following data sheet if applicable. The rest of the surgical procedure is as usual. In the postoperative period the investigator collects the data commented in following sections.
The evidence of an anastomotic leak will be tested with analytical and radiological parameters:
Blood samples will be taken from patients at:
Immediate preoperative (blood count, procalcitonin and C-reactive protein)
Days 1, 3, 5 and 7 postoperative (blood count, procalcitonin and C-reactive protein).
A sample of surgical drainage will be collected for the determination of amylases on days: 1,3,5, and 7 postoperative or until drainage is withdrawn.
An abdominal CT with oral contrast will be performed within the first 5 postoperative days. The date and the result will be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Anastomotic Leak
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients won't know if his anastomoses has been reinforced with Tisseel®.
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tisseel®
Arm Type
Active Comparator
Arm Description
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm "Tisseel®" surgeon dispenses the product all over the anastomosis. The rest of the surgical procedure is as usual.
Arm Title
no Tisseel®
Arm Type
Other
Arm Description
Once the esophagojejunal anastomosis is done the patient is randomized (Tisseel® vs no product). In the arm " noTisseel®" surgeon performs the surgical procedure as usual.
Intervention Type
Drug
Intervention Name(s)
Tisseel
Intervention Description
Reinforcement of esophagojejunal anastomoses after total gastrectomy with the product.
Intervention Type
Device
Intervention Name(s)
No Tisseel
Intervention Description
No reinforcement of esophagojejunal anastomoses after total gastrectomy
Primary Outcome Measure Information:
Title
Rate of esophagojejunal anastomotic leak in immediate postoperative period
Description
Clinical or radiological (see anex 1: Score Goense) evidence of esophagojejunal anastomotic leak.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Amylases level in drainage
Description
Amylase level (mg/L) in drainage
Time Frame
days 1,3,5,7 postoperatively
Title
CRP (C-reactive protein) in blood
Description
C-reactive protein in blood (mg/L)
Time Frame
days 1,3,5,7 postoperatively
Title
Procalcitonin in blood
Description
Procalcitonin in blood (mg/L)
Time Frame
days 1,3,5,7 postoperatively
Title
White cell levels in blood
Description
White cell levels in blood (x109/L)
Time Frame
days 1,3,5,7 postoperatively
Title
Results of Computed Tomography with oral contrast.
Description
The results will be expressed based on Goense Score
Based on Score Goense (Anastomotic Leakage Prediction Score). The investigator will collect the presence of:
Yes No Normal Fluid collection Air cavity Fistula Wall discontinuity Empiema
Goense L, Stassen PMC, Wessels FJ, van Rossum PSN, Ruurdal JP, van Leeuwen MS, van Hillegersberg R. Diagnostic performance of a CT-based scoring system for diagnosis of anastomotic leakage after esophagectomy: comparison with subjective CT assessment. Eur Radiol 2017; 27:4426-34
Time Frame
between 3th and 5th postoperative day
Title
Type of esophagojejunal anastomoses performed
Description
The type of esophagojejunal anastomoses performed can be:
mechanical (circular)
mechanical (lineal)
manual
Time Frame
day of intervention
Title
Postoperative complications
Description
Postoperative complications (Clavien-Dindo score):
Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions
Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III Requiring surgical, endoscopic or radiological intervention
IIIa Intervention not under general anesthesia
IIIb Intervention under general anesthesia
Grade IV Life-threatening complication requiring IC/ICU-management
IVa single organ dysfunction (including dialysis)
IVb multiorgandysfunction
Grade V Death of a patient
Time Frame
30 days after surgery
Title
90-day mortality
Description
Mortality at 90 days after surgery
Time Frame
90 days after surgery
Title
Need for urgent surgical re-intervention
Description
Reintervention after surgery:
Yes/Not
Time Frame
30 days after surgery
Title
Hospital stay
Description
Number of days of hospital stay
Time Frame
30 days after surgery
Title
Readmission
Description
Readmission within 30 days after discharge:
Yes/Not
Time Frame
30 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 18 years diagnosed with gastric adenocarcinoma and scheduled for a total gastrectomy with curative intent in EURECCA Esophagogastric Cancer Group who agree to participate in the study and sign the informed consent
Exclusion Criteria:
Patients with non-epithelial neoplasms, with metastases, not resected or undergoing palliative resections. Patients who do not sign informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisenda Garsot
Phone
0034934978803
Email
egarsot@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisenda Garsot
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elisenda Garsot Savall
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yolanda Soler, CRD
Phone
+34 629 760 411
Email
soler.y@recercaclinica.es
First Name & Middle Initial & Last Name & Degree
Sara Sentí, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tisseel® as a Reinforcement of Esophagojejunal Anastomoses
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