Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898517
Status:
COMPLETED
Last Update Posted:
2021-05-26
First Post:
2021-05-11
Brief Title:
Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented CONDUCTJE-ST
Sponsor:
Instituto de Investigación Sanitaria Aragón
Organization:
Instituto de Investigación Sanitaria Aragón
Study Overview
Official Title:
Prevention of Clinically Relevant Postoperative Pancreatic Fistula in Pancreaticoduodenectomy With the Novel Technique of Connexion the Pancreatic Duct to Jejunum Stented CONDUCTJE-ST
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONDUCTJE-ST
Brief Summary:
Objective To assess the efficacy of the connexion pancreatic duct to jejunum stented CONDUCTJE-ST technique to prevent clinically relevant postoperative pancreatic fistula CR-POPF after pancreaticoduodenectomy PD
Summary Background Data CR-POPF remains the most determining cause of morbidity and mortality after PD The incidence of CR-POPF grades B and C ISGPS is around 20 and is a potential source of severe secondary complications that are associated with a mortality of up to 40
Methods A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique the steps of which are described performed by the same surgical team from January 2018 to February 2020 No patient received prophylactic or therapeutic somatostatin or its analogues The primary endpoint was the incidence of CR-POPF Secondary endpoints were postoperative mortality and morbidity hospital course and during the first year of follow-up
In a prospective study we have evaluated a novel technique modification of the preexisting ones for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD termed connexion pancreatic duct to jejunum stented CONDUCTJE-ST applicable to any type of pancreatic remnant regardless of its texture and the diameter of the main pancreatic duct The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD
Summary Background Data CR-POPF remains the most determining cause of morbidity and mortality after PD The incidence of CR-POPF grades B and C ISGPS is around 20 and is a potential source of severe secondary complications that are associated with a mortality of up to 40
Methods A prospective pilot study included 50 consecutive patients who underwent PD with the CONDUCTJE-ST technique the steps of which are described performed by the same surgical team from January 2018 to February 2020 No patient received prophylactic or therapeutic somatostatin or its analogues The primary endpoint was the incidence of CR-POPF Secondary endpoints were postoperative mortality and morbidity hospital course and during the first year of follow-up
In a prospective study we have evaluated a novel technique modification of the preexisting ones for the reconstruction of the digestive continuity of the corporocaudal remnant in the PD termed connexion pancreatic duct to jejunum stented CONDUCTJE-ST applicable to any type of pancreatic remnant regardless of its texture and the diameter of the main pancreatic duct The study was planned with the objective of achieving a significant reduction in the incidence of CR-POPF so that CONDUCTJE-ST could be considered as a surgical procedure of choice in the management of the pancreatic remnant in PD
Detailed Description:
From January 2018 to February 2020 a PD was performed with the CONDUCTJE-ST technique in 50 consecutive patients by the same surgical team whose main surgeon has make more than 250 PD in our Hepatobiliopancreatic Surgery and Liver Transplantation Unit The study was carried out in accordance with the Declaration of Helsinki and was approved by the Research Ethics Committee of the Community of Aragon CEICA Act No 162018 Patient care and study conduct complied with good clinical practices and written informed consent was obtained from each patient
The selection of patients for surgery was decided collectively by the Multidisciplinary Committee for Tumors of the Liver Bile ducts and Pancreas of our hospital No patient received neoadjuvant treatment
Technical aspects
Patients received general anesthesia and multimodal pain therapy with an epidural catheter All patients underwent resection with curative intent performing PD with antrectomy and standard lymphadenectomy Immediately after sectioning the pancreas at the level of the isthmus-body a tissue slice is biopsied from the section margin In the reestablishment of digestive continuity we successively perform four reconstructions The restoration of the flow of pancreatic juice from the corporocaudal remnant towards the intestine was carried out with the technique of connection of the pancreatic duct to the jejunum with stent CONDUCTJE-ST
Patient characteristics
All study data were prospectively recorded The demographic characteristics comorbidities clinical manifestations of the disease and intraoperative parameters were analyzed During the intervention the texture of the remaining pancreatic parenchyma was classified as soft or hard and the diameter of the external orifice of the main pancreatic duct was measured after transection these data were distributed by disease pathology as confirmed by final histological assessment
Patient outcome and follow-up The primary endpoint of the study was the incidence of CR-POPF No patient received prophylactic or therapeutic somatostatin or its analogues According to the 2016 updated of the ISGPS16 POPF has been defined as any volume of fluid collected in the abdominal drainage on postoperative day 3 or from this day with an amylase level 3 times higher than the normal value serum amylase CR-POPF has been considered when the criteria for grades B or C were met while grade A has been replaced by the denomination of biochemical leak 16
The volume and appearance of the fluid from the abdominal drains was recorded daily The amylase concentration in the fluid of each of the drains was analyzed on the third and sixth postoperative days as well as before removing the drain and on any day in which there was a substantial increase in volume or change in the appearance of the fluid The drains were removed when three requirements were met amylase levels in the drainage fluid less than 8 twice the plasma level normal 28-100 U L volume 25 ml day and clear appearance of the fluid
The secondary endpoints of the study were 1 postoperative mortality defined as that which occurred within thirty days of the operation or during the same hospital admission 2 postoperative complications related to the surgical technique delayed gastric emptying DGE digestive and intra-abdominal hemorrhage intra-abdominal abscesses surgical wound infection biliary fistula and gastrointestinal fistula 3 days of stay in the Intensive Care Unit ICU and hospital reoperations and readmissions The DGE and postoperative bleeding were defined according to the ISGPS2930 The severity of complications was classified using the Clavien-Dindo system31 a severe complication was defined as grade IIIa or higher 5 during the first year after PD a the incidence of exocrine pancreatic insufficiency EPI evaluated by the presence of steatorrhea need for pancreatic enzyme supplements and fecal elastase determination b incidence of new-onset diabetes mellitus NODM assessed by blood glucose glycated hemoglobin A1c and need for insulin or oral antidiabetics c overall survival and by pathologies and in the case of malignant processes disease-free survival at 3 6 9 and 12 months after PD
The selection of patients for surgery was decided collectively by the Multidisciplinary Committee for Tumors of the Liver Bile ducts and Pancreas of our hospital No patient received neoadjuvant treatment
Technical aspects
Patients received general anesthesia and multimodal pain therapy with an epidural catheter All patients underwent resection with curative intent performing PD with antrectomy and standard lymphadenectomy Immediately after sectioning the pancreas at the level of the isthmus-body a tissue slice is biopsied from the section margin In the reestablishment of digestive continuity we successively perform four reconstructions The restoration of the flow of pancreatic juice from the corporocaudal remnant towards the intestine was carried out with the technique of connection of the pancreatic duct to the jejunum with stent CONDUCTJE-ST
Patient characteristics
All study data were prospectively recorded The demographic characteristics comorbidities clinical manifestations of the disease and intraoperative parameters were analyzed During the intervention the texture of the remaining pancreatic parenchyma was classified as soft or hard and the diameter of the external orifice of the main pancreatic duct was measured after transection these data were distributed by disease pathology as confirmed by final histological assessment
Patient outcome and follow-up The primary endpoint of the study was the incidence of CR-POPF No patient received prophylactic or therapeutic somatostatin or its analogues According to the 2016 updated of the ISGPS16 POPF has been defined as any volume of fluid collected in the abdominal drainage on postoperative day 3 or from this day with an amylase level 3 times higher than the normal value serum amylase CR-POPF has been considered when the criteria for grades B or C were met while grade A has been replaced by the denomination of biochemical leak 16
The volume and appearance of the fluid from the abdominal drains was recorded daily The amylase concentration in the fluid of each of the drains was analyzed on the third and sixth postoperative days as well as before removing the drain and on any day in which there was a substantial increase in volume or change in the appearance of the fluid The drains were removed when three requirements were met amylase levels in the drainage fluid less than 8 twice the plasma level normal 28-100 U L volume 25 ml day and clear appearance of the fluid
The secondary endpoints of the study were 1 postoperative mortality defined as that which occurred within thirty days of the operation or during the same hospital admission 2 postoperative complications related to the surgical technique delayed gastric emptying DGE digestive and intra-abdominal hemorrhage intra-abdominal abscesses surgical wound infection biliary fistula and gastrointestinal fistula 3 days of stay in the Intensive Care Unit ICU and hospital reoperations and readmissions The DGE and postoperative bleeding were defined according to the ISGPS2930 The severity of complications was classified using the Clavien-Dindo system31 a severe complication was defined as grade IIIa or higher 5 during the first year after PD a the incidence of exocrine pancreatic insufficiency EPI evaluated by the presence of steatorrhea need for pancreatic enzyme supplements and fecal elastase determination b incidence of new-onset diabetes mellitus NODM assessed by blood glucose glycated hemoglobin A1c and need for insulin or oral antidiabetics c overall survival and by pathologies and in the case of malignant processes disease-free survival at 3 6 9 and 12 months after PD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None