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Different Pancreaticojejunostomy After Pancreaticoduodenectomy

Primary Purpose

Pancreaticoduodenectomy, Postoperative Pancreatic Fistula

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
pancreaticojejunostomy
Sponsored by
Junjie Xiong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreaticoduodenectomy focused on measuring pancreaticoduodenectomy, pancreaticojejunostomy, postoperative pancreatic fistula, pancreatic duct

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bole TianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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"

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 11, 2022
Last Updated
July 24, 2022
Sponsor
Junjie Xiong
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1. Study Identification

Unique Protocol Identification Number
NCT05475275
Brief Title
Different Pancreaticojejunostomy After Pancreaticoduodenectomy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Junjie Xiong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreaticoduodenectomy, Postoperative Pancreatic Fistula
Keywords
pancreaticoduodenectomy, pancreaticojejunostomy, postoperative pancreatic fistula, pancreatic duct

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were randomly divided into the experimental group and the control group.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Enclosed envelope
Allocation
Randomized
Enrollment
924 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The patients in the control group were given "traditional pancreaticojejunostomy"
Intervention Type
Procedure
Intervention Name(s)
pancreaticojejunostomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pancreatic fistula(POPF) as assessed by 2016 ISGPS definition
Description
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.
Time Frame
Within 30 days
Secondary Outcome Measure Information:
Title
Postoperative hemorrhage as assessed by ISGPS definition
Description
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.
Time Frame
Within 30 days
Title
Delayed gastric emptying as assessed by ISGPS definition
Description
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.
Time Frame
Within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bole Tian, MD
Phone
86-28-85422474
Email
hxtbl0338@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junjie Xiong, MD
Phone
86-28-85422474
Email
junjiex2011@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bole Tian, MD
Organizational Affiliation
West China Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bole Tian
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bole Tian, MD
Phone
86-28-85422474
Email
hxtbl0338@163.com
First Name & Middle Initial & Last Name & Degree
Junjie Xiong, MD
Phone
86-28-85422474
Email
junjiex2011@126.com
First Name & Middle Initial & Last Name & Degree
Lang Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34044806
Citation
Wu C, Hou SZ, Wu Z, Huang X, Wang Z, Tian B. Prognostic Nomogram for patients undergoing radical Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. BMC Cancer. 2021 May 27;21(1):624. doi: 10.1186/s12885-021-08295-5.
Results Reference
result
PubMed Identifier
28384642
Citation
Wang WG, Fu L, Babu SR, Wang L, Liang CP, Tian BL. Incidence of and Risk Factors and Reinterventions for Post-Pancreatoduodenectomy Hemorrhage: Retrospective Analysis. Dig Surg. 2018;35(1):19-27. doi: 10.1159/000460263. Epub 2017 Apr 7.
Results Reference
result
PubMed Identifier
24095023
Citation
Su AP, Zhang Y, Ke NW, Lu HM, Tian BL, Hu WM, Zhang ZD. Triple-layer duct-to-mucosa pancreaticojejunostomy with resection of jejunal serosa decreased pancreatic fistula after pancreaticoduodenectomy. J Surg Res. 2014 Jan;186(1):184-91. doi: 10.1016/j.jss.2013.08.029. Epub 2013 Sep 21.
Results Reference
result
PubMed Identifier
23918152
Citation
Su AP, Ke NW, Zhang Y, Wang WG, Zhang ZD, Liu XB, Hu WM, Tian BL. Does modified Braun enteroenterostomy improve alkaline reflux gastritis and marginal ulcer after pancreaticoduodenectomy? Dig Dis Sci. 2013 Nov;58(11):3224-31. doi: 10.1007/s10620-013-2803-x. Epub 2013 Aug 6.
Results Reference
result
PubMed Identifier
29697455
Citation
Hirono S, Kawai M, Okada KI, Miyazawa M, Kitahata Y, Hayami S, Ueno M, Yamaue H. Modified Blumgart Mattress Suture Versus Conventional Interrupted Suture in Pancreaticojejunostomy During Pancreaticoduodenectomy: Randomized Controlled Trial. Ann Surg. 2019 Feb;269(2):243-251. doi: 10.1097/SLA.0000000000002802.
Results Reference
result
PubMed Identifier
28594741
Citation
Ecker BL, McMillan MT, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Dickson EJ, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, Haverick E, Hollis RH, House MG, Hughes SJ, Jamieson NB, Javed AA, Kent TS, Kowalsky SJ, Kunstman JW, Malleo G, Poruk KE, Salem RR, Schmidt CR, Soares K, Stauffer JA, Valero V, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM Jr. Characterization and Optimal Management of High-risk Pancreatic Anastomoses During Pancreatoduodenectomy. Ann Surg. 2018 Apr;267(4):608-616. doi: 10.1097/SLA.0000000000002327.
Results Reference
result
PubMed Identifier
26135690
Citation
Keck T, Wellner UF, Bahra M, Klein F, Sick O, Niedergethmann M, Wilhelm TJ, Farkas SA, Borner T, Bruns C, Kleespies A, Kleeff J, Mihaljevic AL, Uhl W, Chromik A, Fendrich V, Heeger K, Padberg W, Hecker A, Neumann UP, Junge K, Kalff JC, Glowka TR, Werner J, Knebel P, Piso P, Mayr M, Izbicki J, Vashist Y, Bronsert P, Bruckner T, Limprecht R, Diener MK, Rossion I, Wegener I, Hopt UT. Pancreatogastrostomy Versus Pancreatojejunostomy for RECOnstruction After PANCreatoduodenectomy (RECOPANC, DRKS 00000767): Perioperative and Long-term Results of a Multicenter Randomized Controlled Trial. Ann Surg. 2016 Mar;263(3):440-9. doi: 10.1097/SLA.0000000000001240.
Results Reference
result

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Different Pancreaticojejunostomy After Pancreaticoduodenectomy

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