Modified Reconstruction for Pancreatic Head Resection

NCT03277625 | Unknown DMC

• 1 other identifier: 16-5706
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to prove the safety and efficacy of a modified method of reconstruction after pancreatic head resection utilizing a single Omega shaped intestinal Loop with an additional anastomosis between the pancreatic and biliary anstomoses. This simple and fast method is expected to provide the advantages of a double-loop reconstruction without adding time and difficulty to the reconstruction process during pancreaticoduodenectomy. The additional intestinal anastomosis should allow Diversion of pancreatic Juice from bile thus reducing the severity of possible postoperative pancreatic Fistula, especially in the subgroup of patients undergoing a pancreaticoduodenectomy and having a high-risk pancreatic remnant, i.e. very soft, fragile and fatty pancreas with a tiny, non-dilated pancreatic main duct. The Primary Point of the study ist the severity of postoperative pancreatic Fistula, as well as the total rate of severe postoperative complications, defined as Grade 3b or more according to the classification of Dindo-Clavien.

Conditions

Pancreaticoduodenal; Fistula

Keywords

pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Severity of postoperative pancreatic fistula

  grade B and grade C Fistula as clinically relevant

  from postoperative day 3 until postoperative day 30

Secondary Outcomes (1)

• Major postoperative complications

  postoperative days 1 to 30

Study Arms (1)

pancreaticoduodenectomy

patients undergoing pancreticoduodenectomy and having a soft, fragile and/or fatty pancreatic remnant, combined with small pancreatic duct having a Diameter \<3 mm.

Procedure: modified omega-shaped single-loop

Interventions

modified omega-shaped single-loop PROCEDURE

A double-layer, end-to-side, duct-to-mucosa PJ using interrupted polydioxanone 5-0 suture (PDS II, Ethicon, Somerville, USA) for the outer layer and interrupted polypropylene 5-0 suture (Prolene, Ethicon, USA) for the inner layer is the standard technique during PD at our Institution. For the modified omega-shaped single-Loop reconstruction the loop between PJ and HJ is left intentionally longer at about 25-30 cm and an additional side-to-side jejunojejunal anastomosis is performed at the lowest point between the afferent and efferent loops of the HJ This intestinal anastomosis is done in a double-layer continuous PDS 5-0 suture technique. Neither sealants, nor stents are being applied at the PJ. In cases of thin walled and tiny hepatic ducts, the HJ is splinted using an externally diverted T-tube.

pancreaticoduodenectomy

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients undergoing elective and emergency pancreaticoduodenectomy irrespective of diagnosis. the typical Patient is an obese, old, has a small pancreatic lesion, either cystic or solid, not leading to obstruction of the pancreatic duct or the biliary duct.

You may qualify if:

• pancreaticoduodenectomy
• soft, fragile or fatty pancreatic remnant combined with pancreatic duct \<3mm

You may not qualify if:

• soft pancreas, but large pancreatic duct\>3mm
• small pancreatic duct \<3mm, but hard pancreatic remnant

Sponsors & Collaborators

• St. Josef Hospital Bochum: lead

Study Sites (1)

Department of Surgery, St. Josef Hospital, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

MeSH Terms

Conditions

Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Orlin Belyaev, MD, PhD

CONTACT

00492345092212; orlin.belyaev@gmx.de

Ilgar Aghalarov

CONTACT

00492345090; i.aghalarov@klinikum-bochum.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 11, 2017
• Study Start: January 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)