A successfully conducted trial will have a positive impact on the future handling of thepancreatic remnant in distal pancreatectomy. The reliable and comparable data generated in this trial may support an evidence-based choice of a surgical…
ID
Source
Brief title
Condition
- Exocrine pancreas conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Combined primary endpoint:
· Occurence of a pancreatic fistula.
· Death due to any cause until the postoperative day 7.
Secondary outcome
1. Surgical category
· Operating time [min] from resection to beginning of closure of the abdomen
· Total operating time [min]
· Frequency of burst abdomen
· Frequency of wound infection
· Frequency of intra-abdominal fluid collection rated as abscess that requires
an intervention
(surgery, drainage, antibiotic treatment)
2. Non-surgical category
· postoperative length of hospital stay
· Frequency of new onset diabetes mellitus (necessity of new anti-diabetic drug
treatment)
· One-year survival
Background summary
After distal pancreatectomy, the appropriate closure of the remnant is still
debated. All resections of this endocrine organ to the left side of the
superior mesenteric vein are defined as distal pancreatectomy. Distal
pancreatic resections are performed less frequently (15% of all pancreatic
resections in Heidelberg) compared to resections of the head due to lower
incidence and later appearance of clinical symptoms. Nevertheless, the
improving imaging and diagnostic techniques account for an increase in
frequency of distal pancreatic resections due to pancreatic disease. Most
patients (84%) are treated as elective cases for the following indications:
chronic pancreatitis (24%), other benign diseases (22%), malignant diseases
(18%), neuroendocrine tumours (14%), and cysts of the pancreas (6%). The
remaining 16% are emergency cases after abdominal trauma. In the past years,
mortality after pancreatic resections has decreased considerably in high volume
centers, with still a high morbidity 3,4. Pancreatic fistula and leakage are
the most common and most relevant complications due to surgical technique and
skill. The major complication after distal pancreatectomy is the occurrence of
a pancreatic fistula. Since fistulae are associated with local and general
complications (pancreatic fluid collection, formation of intra-abdominal
abscesses, wound infection, delayed gastric emptying, respiratory
complications, sepsis and bleeding), they have several relevant implications
for the patient, the surgeon and the health care system. This morbidity causes
a prolongation of hospital stay due to the additional need for specialised
treatment including invasive procedures such as additional
surgery or interventional drainage. A recent systematic review and
meta-analysis evaluated all available surgical techniques of distal
pancreatectomy, in particular with regard to the occurrence of pancreatic
fistulae: handsewn suture techniques versus stapled closure and combination of
both, ultrasonic dissection devices, pancreatico-enteric anastomosis,
application of meshes, or sealing by
use of fibrin glue. As expected, stapler-closure and hand-sewn closure of the
pancreas were found to be the most common techniques. The reported
postoperative morbidity varies between 13.2% and 64%. The primary outcome
measure, pancreatic fistula, occurred within a range from 0% - 61%.
Meta-analysis of stapler versus hand-sutured closure (one RCT; five
observational studies) showed a nonsignificant (P = 0.21) combined odds ratio
for the occurrence of a pancreatic fistula of 0.66 (95 % confidence interval
0.35 to 1.26) in favour of stapler-closure.
Study objective
A successfully conducted trial will have a positive impact on the future
handling of the
pancreatic remnant in distal pancreatectomy. The reliable and comparable data
generated in this trial may support an evidence-based choice of a surgical
technique out of a wide range of existing techniques. The reduction of the
fistula rate, as the major complication of distal pancreatectomy, may lead to a
decrease in further associated complications. In particular, the length of
hospital stay and additional interventional procedures can be reduced and a
return to full recovery will be accelerated. Additionally, costs of the
post-operative treatment may be reduced as to the impact on the health care
system. Moreover, this multi-center approach may show that the introduced
technique is appropriate for different settings and therefore shall be
transferable to other health care institutions. After analysis and statistical
evaluation, results will be published in a scientific medical journal.
Publication of the trial protocol is in preparation.
Study design
The trial is designed to show that the risk of developing a pancreatic fistula
and/or death after the surgical procedure can be reduced by stapler-closure
compared to scalpel transsection and handsutured closure of the pancreatic
remnant following distal pancreatectomy. The following hypothesis will be
tested:
H0: The risk of morbidity (pancreatic fistula) combined with mortality is equal
in both
groups.
H1: The risk of morbidity (pancreatic fistula) combined with mortality is
different between both groups.
Intervention
1. Scalpel transsection of the pancreas and hand-sewn closure of the pancreatic
remnant
2. Stapler-transsection of the pancreas and stapler-closure of the pancreatic
remnant
Study burden and risks
n/a
Im Neuenheimer Feld 110
69120 Heidelberg
DE
Im Neuenheimer Feld 110
69120 Heidelberg
DE
Listed location countries
Age
Inclusion criteria
· Age equal or above 18 years
· Expected survival time more than 12 months
· Patients with at least one of the following pathologic diseases scheduled for
elective resection:
- Resectable malignancies of the pancreatic body and/or tail
- Resectable chronic pancreatitis of the body and/or tail
- Resectable benign tumours of the pancreas including neuroendocrine tumours
- Resectable pseudocyst of the pancreatic body and/or tail
Exclusion criteria
· Current immunosuppressive therapy
· Chemotherapy within 2 weeks before operation
· Radiotherapy within 8 weeks before operation
· Curative resection is not feasible
· Severe psychiatric or neurologic diseases
· Drug- and/or alcohol-abuse according to local standards
· Participation in another intervention-trial with interference of intervention or
outcome
· Inability to follow the instructions given by the investigator or interviewer
· Expected lack of compliance
· Lack of informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 18452029 |
| CCMO | NL16261.018.07 |