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The purpose of this trial is to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness.
Distal pancreatectomy (DP) is the standard treatment for symptomatic benign, premalignant, and malignant lesions in the pancreatic body and tail.Laparoscopic distal pancreatectomy (LDP) are reported to have lower blood loss, fewer postoperative complications and a shorter length of stay without a substantial increase in the operative time. Pancreatic fistula (PF) is the major source of postoperative morbidity and is associated with numerous further complications, suffering, longer hospital stay, higher costs and sometimes death. Frequencies range from 5% to 64%. Several procedures have been proposed to reduce the rate of PF. stapler closure is considered to be safe and approved particularly in LDP. Numerous predictive factors for PF have been reported in previous studies. Among these risk factors, the most important might be the texture and thickness of the remnant pancreas. However, the judgment of pancreatic texture has been based on the surgeon's observation and there still exists no objective method of assessing pancreatic texture. Furthermore there is no strict guideline on which type of cartridge to use according to pancreatic stump texture and thickness. Therefore, this single blind randomized controlled trial is designed to establish an objective criterion for assessing pancreatic stump texture, and unify stapler cartridge according to pancreatic stump texture and thickness. Patients were stratified intraoperatively by gland texture-hard (fibrotic) or soft (normal) and subsequently randomized according to different stapler cartridge. Pancreatic fibrosis is accessed by histopathology and pancreatic stellate cell.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tri-Staple reloads | Experimental | Tri-Staple reloads were used for pancreatic stump texture |
|
| traditional reloads | Active Comparator | the traditional reloads were used for pancreatic stump texture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| traditional reloads | Procedure | Blue cartridge with3.0mm height staple was used for pancreatic stump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pancreatic fistula grade A/ B/C defined by ISGPF classification | Pancreatic amylase concentration in any post operative drains. Fistula is diagnosed if pancreatic amylase > 3 times the upper normal limit of pancreatic amylase in plasma on post operative day 3 or later | Thirty days after operation |
| Pancreatic fibrosis accessed by histopathology and pancreatic stellate cell | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Thirty days after operation | |
| Mortality | Thirty days after operation | |
| Time to oral intake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YiPing Mou, MD | Department of Gastrointestinal-Pancreatic Surgery, Zhejiang Provincial Peoples' Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial Peoples' Hospital | Hangzhou | Zhejiang | 310014 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Tri-Staple reloads | Procedure | Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump |
|
| Duration of hospital stay |
| Postoperative hospital stay | Duration of hospital stay |
| Readmission rate | Thirty days after operation |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |