Modified Reconstruction for Pancreatic Head Resection

Safety and Efficacy of Modified Single-loop Omega-shaped Reconstruction After Pancreaticoduodenectomy in Patients With High-risk Pancreas

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.

Study Overview

• Status: Unknown
• Conditions: Pancreaticoduodenal; Fistula
• Intervention / Treatment: Procedure: modified omega-shaped single-loop

Detailed Description

Postoperative pancreatic fistula (POPF) is the most common and specific complication of pancreaticoduodenectomy (PD) with reported rates of over 20% even at high-volume centers. POPF may cause life-threatening secondary complications such as postpancreatectomy hemorrhage (PPH), intraabdominal abscess, and sepsis, leading to increased costs, prolonged hospital stay as well as to delayed chemotherapy in oncologic patients.

A myriad of innovations in surgical technique has been introduced over the last several decades in order to reduce the rate and severity of POPF. One of these includes the double-loop (DL) reconstruction with isolated Roux-en-Y loops for the pancreatic and biliary anastomoses. It was first described in 1976 by Machado and has afterwards been applied by many surgeons in different variations. The method is based on the empirical hypothesis that diverting bile away from pancreatic juice may prevent their mutual activation and thus decrease their aggressiveness and detrimental effect on the pancreaticojejunostomy (PJ). Theoretically, reduction in the rate and severity of POPF should be expected. Some randomized controlled trials (RCT) reported decreased severity of POPF and lower rates of associated morbidity, whereas others failed to confirm these positive results. A substantially prolonged duration of surgery was observed in most of the studies.

In order to reduce the rate and severity of POPF without prolonging duration of surgery, we introduced in 2015 a new method of reconstruction during PD using a single long intestinal loop with a side-to-side anastomosis between the afferent and efferent limbs of the hepaticojejunostomy (HJ) similar to a Braun anastomosis in a Billroth II resection. It aimed at increasing the distance between the pancreatic and biliary anastomotic sites and facilitating isolated flow of bile and pancreatic secretions in a simple, fast and straightforward manner without the need for a time-consuming and sometimes technically challenging DL reconstruction.

This study aims to reveal how the new modified single-loop (mSL) method of reconstruction compares to the conventional single loop (SL) and DL methods in terms of severity and rate of POPF as well as associated major complications after PD in high-risk patients with a soft pancreatic remnant and a small pancreatic duct.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bochum, NRW, Germany, 44791
      • Recruiting
      • Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
      • Contact: Orlin Belyaev, MD; Phone Number: +49 234 509 0; Email: o.belyaev@klinikum-bochum.de
      • Contact: Waldemar Uhl, MD, PhD; Phone Number: +49 234 509 2211; Email: w.uhl@klinikum-bochum.de
      • Principal Investigator: Ilgar Aghalarov
      • Principal Investigator: Orlin Belyaev, MD
      • Principal Investigator: Waldemar Uhl, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 94 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative pancreatic fistula	grade B and grade C Fistula as clinically relevant	from postoperative day 3 until postoperative day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major postoperative complications	all type of postoperative complications grades 3b, 4 and 5 (mortality) after Dindo-Clavien	postoperative days 1 to 30

Collaborators and Investigators

• Sponsor: St. Josef Hospital Bochum

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: 16-5706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No