Pancreaticoduodenal; FistulaNCT03277625
Modified Reconstruction for Pancreatic Head Resection
An observational study of Pancreaticoduodenal; Fistula, run by St. Josef Hospital Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Pancreaticoduodenal; Fistula
- What is being tested?
- modified omega-shaped single-loop
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2015to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- pancreaticoduodenectomy
- soft, fragile or fatty pancreatic remnant combined with pancreatic duct <3mm
Who cannot join
- soft pancreas, but large pancreatic duct>3mm
- small pancreatic duct <3mm, but hard pancreatic remnant
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, 44791
Orlin Belyaev, MD, +49 234 509 0, o.belyaev@klinikum-bochum.de
Waldemar Uhl, MD, PhD, +49 234 509 2211, w.uhl@klinikum-bochum.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreaticoduodenal; Fistula
- Being tested
- modified omega-shaped single-loop
- Keywords
- pancreaticoduodenectomy
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified omega-shaped single-loopProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| pancreaticoduodenectomy | patients undergoing pancreticoduodenectomy and having a soft, fragile and/or fatty pancreatic remnant, combined with small pancreatic duct having a Diameter <3 mm. Receives: Procedure: modified omega-shaped single-loop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of postoperative pancreatic fistula
grade B and grade C Fistula as clinically relevant
Measured: from postoperative day 3 until postoperative day 30
Secondary outcomes (1)
Major postoperative complications
all type of postoperative complications grades 3b, 4 and 5 (mortality) after Dindo-Clavien
Measured: postoperative days 1 to 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Jan 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreaticoduodenal; FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Josef Hospital Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orlin Belyaev, St. Josef Hospital Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277625
- Sponsor's protocol ID
- 16-5706
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Modified Single-loop Omega-shaped Reconstruction After Pancreaticoduodenectomy in Patients With High-risk Pancreas
- ClinicalTrials.gov ID
- NCT03277625
- Acronym / sponsor ID
- 16-5706
- Conditions
- Pancreaticoduodenal; Fistula
- Keywords
- pancreaticoduodenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St. Josef Hospital BochumUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreaticoduodenectomy | – | Procedure: modified omega-shaped single-looppatients undergoing pancreticoduodenectomy and having a soft, fragile and/or fatty pancreatic remnant, combined with small pancreatic duct having a Diameter <3 mm. |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- pancreaticoduodenectomy
- soft, fragile or fatty pancreatic remnant combined with pancreatic duct <3mm
Key exclusion criteria (2 listed)
- soft pancreas, but large pancreatic duct>3mm
- small pancreatic duct <3mm, but hard pancreatic remnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified omega-shaped single-loopA 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. | Procedure or surgery | pancreaticoduodenectomy |
Primary outcome
Severity of postoperative pancreatic fistula
Time frame: from postoperative day 3 until postoperative day 30
grade B and grade C Fistula as clinically relevant
1 secondary outcome
Major postoperative complications
Time frame: postoperative days 1 to 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Pancreaticoduodenal; Fistula
Not yet recruiting
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
Pancreatic Fistula, Pancreaticoduodenal; Fistula
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreaticoduodenal; Fistula, run by St. Josef Hospital Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orlin Belyaev, MD, PhD (00492345092212, orlin.belyaev@gmx.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of postoperative pancreatic fistula (time frame: from postoperative day 3 until postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.