Modified Reconstruction for Pancreatic Head Resection

September 7, 2017 updated by: Orlin Belyaev, St. Josef Hospital Bochum

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44791
        • Recruiting
        • Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ilgar Aghalarov
        • Principal Investigator:
          • Orlin Belyaev, MD
        • Principal Investigator:
          • Waldemar Uhl, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of postoperative pancreatic fistula
Time Frame: from postoperative day 3 until postoperative day 30
grade B and grade C Fistula as clinically relevant
from postoperative day 3 until postoperative day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major postoperative complications
Time Frame: postoperative days 1 to 30
all type of postoperative complications grades 3b, 4 and 5 (mortality) after Dindo-Clavien
postoperative days 1 to 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Josef Hospital Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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