Different Pancreaticojejunostomy After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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The aim of this study was to reduce the incidence of postoperative pancreatic fistula after pancreaticoduodenectomy by using different pancreaticojejunostomy methods according to the position of the pancreatic duct.

Detailed Description
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Pancreatectomy, especially pancreaticoduodenectomy, is the most complicated surgical approach in all abdominal surgeries. Postoperative pancreatic fistula (POPF) is the most serious complication after pancreaticoduodenectomy. Once it occurs, it will affect postoperative recovery, increase abdominal infection, and even lead to postoperative hemorrhage and life-threatening conditions. The quality of pancreaticojejunostomy has an inevitable relationship with postoperative pancreatic fistula. At present, there are many studies based on the risk factors for pancreatic fistula, including the texture of the pancreas, the diameter of the pancreatic duct, the patient's general condition and other factors, but little attention has been given to the position of the pancreatic duct in the residual pancreatic section. At present, the choice of pancreaticojejunostomy is more arbitrary. Although duct-to-mucosa pancreaticojejunostomy has become mainstream, there are still great differences. At present, there is no pancreaticojejunostomy that can completely avoid the occurrence of pancreatic fistula. The investigators found that the anatomical position of the pancreatic duct in pancreatic section was very important in pancreaticoduodenectomy and divided them into the central type and eccentric type. It was initially found that the incidence of pancreatic fistula after an eccentric pancreatic duct was significantly increased. It was confirmed that the anatomical position of the pancreatic duct is related to the occurrence of POPF. On this basis, the investigators proposed that different types of pancreatic ducts using different anastomosis methods, which may reduce the incidence of POPF. The study data come from the Department of Pancreatic Surgery, West China Hospital, Sichuan University, and the sample size is estimated from the number of patients admitted to the Department of Pancreatic Surgery in the past two years according to the POPF rate. The participants were randomly divided into the experimental group and the control group. The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The central pancreatic duct group was given 1+1 mode pancreaticojejunostomy; the eccentric pancreatic duct group was given 1+1² mode pancreaticojejunostomy. The patients in the control group were given traditional pancreaticojejunostomy. The preoperative basic conditions and postoperative clinically relevant pancreatic fistula and other complications were compared between the two groups. This is expected to be confirmed by the investigators basing on the different types of pancreatic ducts, and the corresponding pancreaticojejunostomy can reduce the incidence of postoperative pancreatic fistula in patients undergoing pancreaticoduodenectomy. The primary outcome was the rate of POPF, and the secondary outcomes included postoperative hemorrhage, postoperative biliary fistula, delayed gastric emptying and so on. Preoperative baseline characteristic data were collected, including age, sex, BMI, ASA, preoperative serum protein level, preoperative blood total bilirubin level, and so on. The postoperative complications and recovery data were collected.

Official Title
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A Prospective Randomized Controlled Trial of the Effect of Different Pancreaticojejunostomy After Pancreaticoduodenectomy on Postoperative Pancreatic Fistula Based on the Position of the Pancreatic Duct in Pancreatic Section

Conditions
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Pancreaticoduodenectomy, Postoperative Pancreatic Fistula

Intervention / Treatment
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* Procedure: pancreaticojejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of benign or malignant peri-ampullary diseases The participants have age more than18 years The participants have adequate organ function to tolerate surgery Exclusion Criteria: *The participants undergoing other organ surgery at the same time

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were randomly divided into the experimental group and the control group.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The central pancreatic duct group was given 1+1 mode pancreaticojejunostomy; the eccentric pancreatic duct group was given 1+1² mode pancreaticojejunostomy. | Procedure: pancreaticojejunostomy<br>* The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The central pancreatic duct group was given 1+1 mode pancreaticojejunostomy; the eccentric pancreatic duct group was given 1+1² mode pancreaticojejunostomy.<br>|
| Active Comparator: Control group<br>The patients in the control group were given traditional pancreaticojejunostomy | Procedure: pancreaticojejunostomy<br>* The experimental group underwent intraoperative measurements (A: short distance from the center of the pancreatic duct to the edge of the pancreas) and (B: pancreatic thickness). When the ratio of the thickness of the short distance from the center of the pancreatic duct to the edge of the pancreas at the pancreatic section was ≥0.401, it was divided into the N1 group (central pancreatic duct). If the ratio was <0.401, it was divided into the N2 group (eccentric pancreatic duct). The central pancreatic duct group was given 1+1 mode pancreaticojejunostomy; the eccentric pancreatic duct group was given 1+1² mode pancreaticojejunostomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pancreatic fistula(POPF) as assessed by 2016 ISGPS definition | 2016 ISGPS definition(POPF):A drain output of any measurable volume of fluid with an amylase level >3 times the upper limit of institutional normal serum amylase activity, associated with a clinically relevant development/condition related directly to the postoperative pancreatic fistula. | Within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hemorrhage as assessed by ISGPS definition | Postoperative hemorrhage(ISGPS definition):definition of PPH is based on three parameters: time of onset, location, and severity of hemorrhage: (1)Onset is either early (≤24 hours after end of the index operation) or late (>24 hours); (2) Location is either intraluminal (eg,pancreatic surface, anastomoses, gastric/duodenal ulcer/erosion, or hemobilia) or extraluminal (eg, arterial or venous vessel, operating field, external suture or staple line, or pseudoaneurysm); (3) Severity of bleeding may be mild or severe. | Within 30 days | 
| Delayed gastric emptying as assessed by ISGPS definition | Delayed gastric emptying(ISGPS definition):Delayed gastric emptying represents the inability to return to a standard diet by the end of the first postoperative week and includes prolonged nasogastric intubation of the patient. Three different grades (A, B, and C) were defined based on the impact on the clinical course and on postoperative management. | Within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, pancreaticojejunostomy, postoperative pancreatic fistula, pancreatic duct