Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial

Conditions
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Pancreatectomy, Pancreatic Fistula

Intervention / Treatment
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* Procedure: Pancreatic Stenting
* Procedure: No Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-op Stenting<br>Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy | Procedure: Pancreatic Stenting<br>* Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy<br>|
| Active Comparator: Surgery alone<br>Distal pancreatectomy alone | Procedure: No Stent<br>* No preoperative stenting with distal pancreatectomy alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with postoperative pancreatic fistula | 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 | Day 3 after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants developing post-operative morbidity | Post-operative complications, graded according to the Clavien-Dindo classification, are recorded | 90 days | 
| Number of participants developing post-operative mortality | All cause mortality after operation was recorded | 90 days | 
| Total length of hospital stay of participants | 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 | 90 days after endoscopy and operation | 
| Number of participants developing complications related to Endoscopic Retrograde Cholangiography | All complications occurred after Endoscopic Retrograde Cholangiopancreatography were recorded | 14 days after endoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Pancreatectomy, Pancreatic Fistula