Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).
Condition: Pancreas Disease; Fistula Pancreatic
MeSH terms: Pancreatic Fistula; Pancreatic Diseases; Fistula
Study type: Observational

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.
    

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. 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.
    

Intervention name(s): Pancreaticoduodenectomy with the CONDUCTJE-ST technique
Intervention type(s): Procedure
Intervention description(s): The termed technique "connexion pancreatic duct to the jejunum stented" (CONDUCTJE-ST) in pancreaticoduodenectomy is a novel technique, modification of the pre-existing ones, whose effectiveness lies in the fact that it is not an anastomosis in the strict sense but rather a simple connection for restoring pancreatic juice flow from the pancreatic remnant towards the intestine.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients in whom a pancreaticoduodenectomy (PD) is to be performed due to carcinoma of the
        pancreas head, distal common bile duct, biliopancreatic confluent and duodenum. Also in
        neuroendocrine tumors and pancreatic cystic neoplasms such as intraductal papillary
        mucinous neoplasia and mucinous cystadenoma, and in some forms of chronic pancreatitis.
      
Keywords: Pancreaticoduodenectomy; Postoperative pancreatic fistula