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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-op Stenting | Experimental | Pre-operative pancreatic stent inserted by Endoscopic Retrograde Cholangiography, followed by distal pancreatectomy |
|
| Surgery alone | Active Comparator | Distal pancreatectomy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic Stenting | Procedure | Pancreatic stent of appropriate size and length is inserted to the pancreatic duct before distal pancreatectomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kit Fai Lee, MBBS | Contact | 35051496 | leekf@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Kit Fai Lee, MBBS | Clinical Associate Professor (honorary) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| No Stent | Procedure | No preoperative stenting with distal pancreatectomy alone |
|
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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |