Routine Staple Line Reinforcement for Minimally Invasive Distal Pancreatectomy

Study Overview
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Brief Summary
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Postoperative fistula is the major complications of distal pancreatectomies which prohibit patients' recovery. Previous studies have reported controversial results regarding the efficacy of pancreatic stump reinforcement methods. Prior research has commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult. Data has shown that staple line plus reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Thus, the investigators design the present study to the question that whether routine staple line plus reinforcement would bring benefit for participants.

Detailed Description
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Distal pancreatectomy (DP)is the standard surgical method for benign or malignant pancreatic tumors locating at body and tail [1]. Clinically relevant postoperative pancreatic fistula (CR-POPF) is the major complication after pancreatectomy. In literature, reported CR-POPF rate after distal pancreatectomy varied between 5% and 64% from different centers. It's still a challenge to prevent CR-POPF via effective pancreatic remnant closure and no consensus on the optimal surgical technique has been established. Reported surgical strategies to prevent CR-POPF included stapler transection, staple line reinforcement, stump coverage with autologous tissue or fibrin glue, mesh reinforcement, and prophylactic administration of octreotide. However, none had convincing outcome [2-4]. Data has shown that staple line plus suture reinforcement might potentially decrease the CR-POPF rate of patients who underwent distal pancreatectomies, but well-designed high-quality evidence is lacking. Meanwhile, prior researches have commonly included minimally invasive and open cases together. Moreover, stapler and suture were combined in most studies making interpretation difficult [5-8]. Thus, the investigators design a single-centered, parallel, randomized controlled trial to compare the efficacy of routine staple line plus reinforcement versus staple only on the CR-POPF rate of participants who underwent minimally invasive distal pancreatectomies.

Official Title
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Efficacy of Routine Staple Line Reinforcement Versus no Reinforcement on Pancreatic Fistula After Minimally Invasive Distal Pancreatectomy: A Single Center, Parallel, Randomized Controlled Trial

Conditions
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Surgery--Complications, Pancreas Neoplasm, Stump

Intervention / Treatment
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* Procedure: reinforcement of the staple line
* Procedure: staple only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who will receive distal pancreatectomy via minimally invasive approaches, no matter benign or malignant; Aged from 18 - 80 years; Preoperative diagnosis of serous or mucinous cystic adenoma; Preoperative diagnosis of solid pseudopapillary tumor (SPT); Preoperative diagnosis of neuroendocrine tumor; Preoperative diagnosis of intraductal papillary mucinous neoplasm (IPMN); Preoperative diagnosis of or pseudocyst; Preoperative diagnosis of distal pancreatic malignancies; Patients willing to provide informed consent. Exclusion Criteria: History of upper abdominal surgical history such as splenectomy, gastrectomy, liver resection, duodenal or pancreatic resection (not including laparoscopic cystectomy); Pancreatic trauma; With pneumoperitoneum contraindications; With severe heart or pulmonary diseases which is not fit for surgeries.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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
Interventional Model Description: The study is a single-center, randomized controlled clinical trial. Grouping: the study group is set as staple line plus reinforcement group, in which a lock stitch will be placed after transecting the pancreas with stapler. While the control group is set as staple line with no reinforcement group, in which no additional reinforcement is used after transecting the pancreas with stapler.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Staple line plus reinforcement<br>In this experimental group, a lock stitch will be placed after transecting the pancreas with stapler. | Procedure: reinforcement of the staple line<br>* The operator will perform reinforcement of the staple line with a continuous lock stitch.<br>|
| Other: staple line with no reinforcement<br>In this control group, no additional reinforcement is used after transecting the pancreas with stapler. | Procedure: staple only<br>* The operator transect the pancreas with stapler only, without staple line reinforcement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant postoperative pancreatic fistula (CR-POPF) | CR-POPF is defined according to the revised 2016 version of ISGPS (International Study Group on Pancreatic Surgery) classification and grading of POPF. A CR-POPF is defined as a drain output of any measurable volume of fluid with amylase level greater than 3 times the upper Institutional normal serum amylase level, associated with a clinically relevant development/condition related directly to the POPF. | Postoperative postoperative day 30. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time | Skin-to-skin time | Postoperative postoperative day 30. | 
| Estimated blood loss | Total blood loss during surgery | Postoperative postoperative day 30. | 
| Length of postoperative hospital stay | Days of hospital stay after surgery | Postoperative postoperative day 30. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staple line, Reinforcement, Pancreatic fistula