Pancreatic NeoplasmsNCT01759706
Safety and Feasibility Study of Enhanced Recovery in Pancreaticoduodenectomy
A study testing Enhanced recovery after surgery protocol, Standard perioperative care and PONV prophylaxis with Ondansetron + Dexamethasone in people with Pancreatic Neoplasms, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Enhanced recovery after surgery protocol, Standard perioperative care and PONV prophylaxis with Ondansetron + Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Jan 2013
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing elective pancreaticoduodenectomy
Who cannot join
- Intraoperative detection of metastatic disease (non-operability)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.
The purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).
Read the detailed description
A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Enhanced recovery after surgery protocol, Standard perioperative care, PONV prophylaxis with Ondansetron + Dexamethasone, Postoperative mobilization program, Epidural analgesia with naropin + sufentanil
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced recovery after surgery protocolBehavioural
ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.
Standard perioperative careProcedure or surgery
Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4
PONV prophylaxis with Ondansetron + DexamethasoneDrug
Also called Zofran + Decadron
Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
Postoperative mobilization programOther
Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward
Epidural analgesia with naropin + sufentanilDrug
Also called Disufen
Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
Pre-anesthetic medication with diazepamDrug
Also called Valium
Premedication before general anesthesia
Preadmission counsellingBehavioural
Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
Preoperative bowel preparation with sodium phosphateDrug
Also called Phospho-Lax
Preoperative bowel preparation with oral assumption of sodium phosphate
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Experimental | Patients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter. Receives: Behavioral: Enhanced recovery after surgery protocol; Drug: PONV prophylaxis with Ondansetron + Dexamethasone; Other: Postoperative mobilization program; Drug: Epidural analgesia with naropin + sufentanil; Behavioral: Preadmission counselling |
| Standard perioperative care (Control) | Active comparator | Patients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4 Receives: Procedure: Standard perioperative care; Drug: Epidural analgesia with naropin + sufentanil; Drug: Pre-anesthetic medication with diazepam; Drug: Preoperative bowel preparation with sodium phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the pathway
Adherence to single items of the pathway.
Measured: Participants will be followed from two weeks before surgery, for the duration of hospital stay, and for 30 days after discharge, an expected average of 8 weeks.
Secondary outcomes (1)
Postoperative outcome
Comparison of postoperative morbidity and mortality, length of hospital stay, readmission.
Measured: The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Raffaele
- Responsible party
- Principal investigator, Marco Braga, Università Vita-Salute San Raffaele
- Investigators
- Marco Braga, MD, Principal investigator, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759706
- Sponsor's protocol ID
- ERAS_PANCREAS 01
- Status last verified
- Dec 2014
- First submitted
- 21 Dec 2012
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
PubMed 18844251Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.
PubMed 22956014
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of an Enhanced Recovery After Surgery Protocol in Patients Undergoing Elective Pancreaticoduodenectomy.
- ClinicalTrials.gov ID
- NCT01759706
- Acronym / sponsor ID
- ERAS_PANCREAS 01
- Conditions
- Pancreatic Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Ospedale San Raffaele
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Jan 2013 (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 purpose of this study is to assess the adherence to an enhanced recovery after surgery (ERAS) pathway and the impact of the ERAS protocol on postoperative short-term outcome in patients undergoing pancreaticoduodenectomy (PD).
Detailed description
A specific enhanced recovery after surgery (ERAS) protocol has been applied since October 2010 in consecutive patients undergoing pancreaticoduodenectomy (PD) in a high volume Institution. Patient compliance for each item has been assessed. Each ERAS patient was matched with a patient who received standard perioperative care. Match criteria were age, gender, malignant / benign disease, and PD prognostic score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery (ERAS) | Experimental | Behavioral: Enhanced recovery after surgery protocol, Drug: PONV prophylaxis with Ondansetron + Dexamethasone, Other: Postoperative mobilization program, Drug: Epidural analgesia with naropin + sufentanil, Behavioral: Preadmission counsellingPatients treated with enhanced recovery after surgery protocol: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia with naropin + sufentanil, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV prophylaxis with ondansetron + dexamethasone, hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, postoperative mobilization program, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter. |
| Standard perioperative care (Control) | Active comparator | Procedure: Standard perioperative care, Drug: Epidural analgesia with naropin + sufentanil, Drug: Pre-anesthetic medication with diazepam, Drug: Preoperative bowel preparation with sodium phosphatePatients treated with standard care perioperative protocol: epidural analgesia with naropin + sufentanil, pre-anesthetic medication with diazepam, Preoperative bowel preparation with sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing elective pancreaticoduodenectomy
Key exclusion criteria (1 listed)
- Intraoperative detection of metastatic disease (non-operability)
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 |
|---|---|---|
| Enhanced recovery after surgery protocolERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter. | Behavioural | Enhanced Recovery After Surgery (ERAS) |
| Standard perioperative careEpidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4 | Procedure or surgery | Standard perioperative care (Control) |
| PONV prophylaxis with Ondansetron + DexamethasoneAlso: Zofran + DecadronPostoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone. | Drug | Enhanced Recovery After Surgery (ERAS) |
| Postoperative mobilization programPatient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward | Other | Enhanced Recovery After Surgery (ERAS) |
| Epidural analgesia with naropin + sufentanilAlso: DisufenMidthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL | Drug | Enhanced Recovery After Surgery (ERAS), Standard perioperative care (Control) |
| Pre-anesthetic medication with diazepamAlso: ValiumPremedication before general anesthesia | Drug | Standard perioperative care (Control) |
| Preadmission counsellingPatient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse. | Behavioural | Enhanced Recovery After Surgery (ERAS) |
| Preoperative bowel preparation with sodium phosphateAlso: Phospho-LaxPreoperative bowel preparation with oral assumption of sodium phosphate | Drug | Standard perioperative care (Control) |
Primary outcome
Adherence to the pathway
Time frame: Participants will be followed from two weeks before surgery, for the duration of hospital stay, and for 30 days after discharge, an expected average of 8 weeks.
Adherence to single items of the pathway.
1 secondary outcome
Postoperative outcome
Time frame: The outcomes will be assessed for the duration of hospital stay and for 30 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Background: PubMed 18844251Balzano G, Zerbi A, Braga M, Rocchetti S, Beneduce AA, Di Carlo V. Fast-track recovery programme after pancreatico- duodenectomy reduces delayed gastric emptying. Br J Surg. 2008 Nov;95(11):1387-93. doi: 10.1002/bjs.6324.
- Background: PubMed 22956014Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schafer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. World J Surg. 2013 Feb;37(2):240-58. doi: 10.1007/s00268-012-1771-1. No abstract available.
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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.
Marco Braga, MD principal investigator
Università Vita-Salute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced recovery after surgery protocol, Standard perioperative care and PONV prophylaxis with Ondansetron + Dexamethasone in people with Pancreatic Neoplasms, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 5 Dec 2014. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to the pathway (time frame: Participants will be followed from two weeks before surgery, for the duration of hospital stay, and for 30 days after discharge, an expected average of 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759706, which also lists 2 linked publications.
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 5 Dec 2014.