SurgeryNCT01712971
Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Trial on Standard Open Versus Minimally Invasive Surgery
An observational study of Surgery and Pancreatic Tumour, run by Baki Topal at 1 site in Belgium.
Trial summary
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgery, Pancreatic Tumour, Peri-ampullary Tumour
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to Jun 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from pancreatic or peri-ampullary tumour
Who may be able to join
- Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
- Age between 18 to 80 years
- Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- Pre-operative radiotherapy, chemotherapy, or biological is allowed
- PD for IPMN is allowed
Who cannot join
- Planned concomitant surgical procedures such as simultaneous colonic resection etc.
- Expected/planned reconstruction of the portal vein or superior mesenteric vein
- Any arterial reconstruction at the time of surgery
- Age < 18years
- Pregnancy
- PD for chronic pancreatitis
- PD for pancreatic trauma
- PD for post-ERCP complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.
Read the detailed description
Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD). With advancing technology, data from expert centers suggest minimally invasive or laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show the clinical benefits of LPD vs. OPD.
Advantages of minimally invasive surgery over open surgery are reduced tissue damage, surgical trauma and immunosuppression.
The general objective of this study is to compare the intra-operative efficacy of LPD vs. OPD, and in particular the amount of intra-operative blood loss.
Study design Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.
Two experienced surgeons will perform all procedures; RA will perform the open and BT the laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed for the HJS and the PGS, while the GES will be done with endo-staplers.
Statistical considerations Randomization will take place pre-operatively after informed consent has been obtained. Patients will be randomized into two groups (OPD vs. LPD) using permuted blocks of size 6. This implies that of each series of 6 consecutive patients, three patients will be randomized in each group. There are no stratification variables.
Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.
Reference intra-operative blood loss levels are available from 138 patients (June 2009 - June 2012), without portal vein resection and without additional surgery. Analysis of these data reveals that these values follow a lognormal distribution; the log-transformed blood loss has a normal distribution with mean and standard deviation equal to 6.06 and 0.83, respectively. The corresponding geometric mean equals 427ml. Based on this distribution, 42.4%, 24.7% and 15.1% of the subjects are expected to have blood loss higher than 500, 750 and 1000 ml, respectively. It is assumed that the treatment (LPD) will lead to a 50% reduction of the (geometric) mean. The impact of this assumption on the distribution of the blood loss levels implies that 15.1%, 6.4% and 3.1% of the subjects in the LPD-group are expected to have a blood loss level higher than 500, 750 and 1000 ml, respectively.
Based on a two-sided two-sample pooled t-test of a mean ratio with lognormal data, a total of 50 subjects is needed to detect a two-fold reduction in blood loss (with alpha set at 5%) with 90% power.
- Conditions
- Surgery, Pancreatic Tumour, Peri-ampullary Tumour, Blood Loss
- Keywords
- surgery, pancreas, tumour, blood loss
- Medical subject headings
- Pancreatic Neoplasms, Hemorrhage, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OPD | standard open pancreaticoduodenectomy | |
| LPD | laparoscopic pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-operative blood loss
the amount of intra-operative blood loss (ml) at the end of surgery (d0)
Measured: day 0 (at the end of surgery)
Secondary outcomes (3)
Surgical resection margin
Histopathological examination of surgical resection margins of the resection specimen; done within 30 days after surgery pR0: tumour-free resection margins pR1: tumour involvement of surgical resection margins
Measured: day 30
length of hospital stay after surgery
discharge from hospital after surgery
Measured: day 30; 60; 90; 180
hospital costs
final cost analysis
Measured: year 1 & 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baki Topal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baki Topal, University Hospital, Gasthuisberg
- Investigators
- Baki Topal, MD, PhD, Study director, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712971
- Sponsor's protocol ID
- LPD
- Status last verified
- Sep 2013
- First submitted
- 18 Oct 2012
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Intra-operative Blood Loss in Pancreaticoduodenectomy for Pancreatic or Peri-ampullary Tumors; Monocentric Randomized Trial on Standard Open Versus Minimally Invasive Surgery
- ClinicalTrials.gov ID
- NCT01712971
- Acronym / sponsor ID
- LPD
- Conditions
- Surgery, Pancreatic Tumour, Peri-ampullary Tumour, Blood Loss
- Keywords
- surgery, pancreas, tumour, blood loss
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baki TopalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 24 Oct 2012 (estimated)
- 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.
The incidence of complications after standard open pancreaticoduodenectomy for pancreatic or peri-ampullary tumours is around 50%. The amount of intra-operative blood loss is an important factor that determines the occurrence of postoperative complications. Therefore, any significant reduction of intra-operative blood loss will benefit the peri-operative course.
Detailed description
Pancreaticoduodenectomy (PD) is the only therapeutic option to cure patients suffering from pancreatic head or peri-ampullary tumors. The standard approach in PD is open surgery (OPD). With advancing technology, data from expert centers suggest minimally invasive or laparoscopic PD (LPD) to be safe and feasible, though randomized studies are lacking to show the clinical benefits of LPD vs. OPD.
Advantages of minimally invasive surgery over open surgery are reduced tissue damage, surgical trauma and immunosuppression.
The general objective of this study is to compare the intra-operative efficacy of LPD vs. OPD, and in particular the amount of intra-operative blood loss.
Study design Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.
Two experienced surgeons will perform all procedures; RA will perform the open and BT the laparoscopic procedures. A pylorus-resecting PD will be followed by a trans-mesocolic end-to-side hepatico-jejunostomy (HJS), a pancreatico-gastrostomy (PGS), and an ante-colic gastro-enterostomy (GES). Da Vinci robotic assistance of the reconstruction in LPD is allowed for the HJS and the PGS, while the GES will be done with endo-staplers.
Statistical considerations Randomization will take place pre-operatively after informed consent has been obtained. Patients will be randomized into two groups (OPD vs. LPD) using permuted blocks of size 6. This implies that of each series of 6 consecutive patients, three patients will be randomized in each group. There are no stratification variables.
Monocentric randomized trial to compare the amount of intra-operative blood loss in LPD vs. OPD. Patients expected to undergo portal vein resection/reconstruction or any simultaneous other type of surgery will be excluded from the study.
Reference intra-operative blood loss levels are available from 138 patients (June 2009 - June 2012), without portal vein resection and without additional surgery. Analysis of these data reveals that these values follow a lognormal distribution; the log-transformed blood loss has a normal distribution with mean and standard deviation equal to 6.06 and 0.83, respectively. The corresponding geometric mean equals 427ml. Based on this distribution, 42.4%, 24.7% and 15.1% of the subjects are expected to have blood loss higher than 500, 750 and 1000 ml, respectively. It is assumed that the treatment (LPD) will lead to a 50% reduction of the (geometric) mean. The impact of this assumption on the distribution of the blood loss levels implies that 15.1%, 6.4% and 3.1% of the subjects in the LPD-group are expected to have a blood loss level higher than 500, 750 and 1000 ml, respectively.
Based on a two-sided two-sample pooled t-test of a mean ratio with lognormal data, a total of 50 subjects is needed to detect a two-fold reduction in blood loss (with alpha set at 5%) with 90% power.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPD | – | –standard open pancreaticoduodenectomy |
| LPD | – | –laparoscopic pancreaticoduodenectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from pancreatic or peri-ampullary tumour
Key inclusion criteria (5 listed)
- Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
- Age between 18 to 80 years
- Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- Pre-operative radiotherapy, chemotherapy, or biological is allowed
- PD for IPMN is allowed
Key exclusion criteria (8 listed)
- Planned concomitant surgical procedures such as simultaneous colonic resection etc.
- Expected/planned reconstruction of the portal vein or superior mesenteric vein
- Any arterial reconstruction at the time of surgery
- Age < 18years
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
intra-operative blood loss
Time frame: day 0 (at the end of surgery)
the amount of intra-operative blood loss (ml) at the end of surgery (d0)
3 secondary outcomes
Surgical resection margin
Time frame: day 30
length of hospital stay after surgery
Time frame: day 30; 60; 90; 180
hospital costs
Time frame: year 1 & 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
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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.
Baki Topal, MD, PhD study director
Universitaire Ziekenhuizen KU Leuven
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 Surgery and Pancreatic Tumour, run by Baki Topal at 1 site in Belgium.
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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 17 Sep 2013. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra-operative blood loss (time frame: day 0 (at the end of surgery)). 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 17 Sep 2013.