Pancreatectomy, Pancreatic Fistula
Conditions
Keywords
Distal Pancreatectomy, Pancreatic Fistula
Brief summary
Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.
Detailed description
A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.
Interventions
PROCEDUREPancreatic Stenting
Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy
PROCEDURENo Stent
No preoperative stenting with distal pancreatectomy alone
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years * Elective distal pancreatectomy for primary pancreatic pathology
Exclusion criteria
* Informed consent not available * Emergency distal pancreatectomy * Presence of pancreatic duct stricture * Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy) * History of severe pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative pancreatic fistula | Day 3 after operation | The number of participants developing post-operative pancreatic fistula, which is defined as drain fluid amylase more than 3 times the upper limit of the normal value of serum amylase on or after postoperative day 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants developing complications related to Endoscopic Retrograde Cholangiography | 14 days after endoscopy | All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded |
| Number of participants developing post-operative morbidity | 90 days | Post-operative complications, graded according to the Clavien-Dindo classification, are recorded |
| Number of participants developing post-operative mortality | 90 days | All cause mortality after operation was recorded |
| Total length of hospital stay of participants | 90 days after endoscopy and operation | The total number of days spent in hospital calculated from the day of admission to discharge for every participant, including the time spent for pre-operative endoscopy and operation |
Countries
Hong Kong
Contacts
Primary ContactKit Fai Lee, MBBS
Outcome results
None listed