Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04898517 |
| Other study ID # |
CONDUCTJE-ST IN PD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
May 2021 |
| Source |
Instituto de Investigación Sanitaria Aragón |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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. 16/2018. 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 ISGPS29,30. 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.
