Prevention of CR-POPF in PD With the Technique of Connexion the Pancreatic Duct to Jejunum Stented (CONDUCTJE-ST).

NCT04898517 | Completed

• 1 other identifier: CONDUCTJE-ST IN PD
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Disease; Fistula Pancreatic

Keywords

Pancreaticoduodenectomy; Postoperative pancreatic fistula

Outcome Measures

Primary Outcomes (1)

• Incidence of clinically relevant postoperative pancreatic fistula after pancreaticoduodenectomy

  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 CR-POPF has been considered when the criteria for grades B or C were met, while grade A has been replaced by the denomination of biochemical leak. 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.

  From surgery up to 30 days after pancreaticoduodenectomy

Secondary Outcomes (6)

• Postoperative mortality

  From surgery to 30 days after pancreaticoduodenectomy

• Delayed gastric emptying (DGE)

  From surgery up to 30 days after pancreaticoduodenectomy

• Postoperative hemorrhage

  From surgery up to 30 days after pancreaticoduodenectomy

• Severity of postoperative complications

  From surgery up to 30 days after pancreaticoduodenectomy

• Incidence of exocrine pancreatic insufficiency

  One year after pancreaticoduodenectomy.

Interventions

Pancreaticoduodenectomy with the CONDUCTJE-ST technique PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age\> 18 years
• informed surgical and anesthetic consents
• scheduled surgical intervention
• intention to carry out PD with the CONDUCTJE-ST technique

You may not qualify if:

• emergency PD
• performing another pancreatic resection technique other than PD
• associated resection of another viscus
• metastasis or locally advanced unresectable tumor detected during surgery.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

University Clinic Hospital Lozano Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Pancreatic Diseases; Pancreatic Fistula

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Francisco A. García-Gil, MD

  Instituto de Investigación Sanitaria Aragón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 24, 2021
• Study Start: January 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 28, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)