Pancreatic Neoplasms; Periampullary NeoplasmsERAMIPNCT02671357
Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy
An observational study of Pancreatic Neoplasms; Periampullary Neoplasms, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Neoplasms; Periampullary Neoplasms
- What is being tested?
- ERAMIP
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2016to Jun 2019
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic or peri-ampullarf neoplasms to undergo minimally invasive pancreaticoduodenectomy
Who may be able to join
- Patients, male or female, who undergo MIP + sPG for a pancreatic or peri-ampullary tumor
- Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- Patients fit for minimally invasive pancreaticoduodenectomy (MIP)
- Informed consent signed
Who cannot join
- Pregnancy
- MIP for pancreatic trauma
- MIP for complications of endoscopic retrograde cholangio-pancreaticography (ERCP)
- Reconstruction of the portal vein or superior mesenteric vein
- Any arterial reconstruction at the time of surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy
This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery after surgery (ERAS) program with early enteral nutrition (EEN).
Read the detailed description
Pancreaticoduodenectomy (PD) is the standard of care for patients with malignant or benign disease of the pancreatic head or peri-ampullary region. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF) and/or delayed gastric emptying (DGE). In a recent multicentre randomized controlled trial, the investigators have shown pancreaticogastrostomy (PG; without a stent in the pancreatic duct) to be associated with 8% POPF rate, significantly lower than pancreaticojejunostomy (20%) (1). Since then, PG reconstruction is considered the standard of care in PD, which is also underlined in more recent systematic reviews.
In patients without POPF after PD, the length of hospital stay is determined by the occurrence of DGE, which is poorly understood and currently lacks any effective treatment. Patients who developed DGE after PD with PG anastomosis (n=18; 20%) had a significantly (p=0.014) longer (mean + sem) length of hospital stay (LOS) of 26.3 + 1.58 days, as compared to 22.4 + 1.27 days for patients without DGE (n=69). These figures are observed in the investigators' center as part of the multicentre RCT.
Enhanced recovery after surgery (ERAS) or fast-track (FT) programs are able to reduce postoperative length of hospital stay (LOS). Indeed recently, ERAS or FT programs have been implemented successfully in PD (2). Patients were discharged 4 days earlier in the ERAS group, without a negative effect on the clinical outcome. Still, many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety.
In efforts to improve the outcomes of PD, many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD. However, the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive, i.e. 2- or 3-dimensional laparoscopic (3D-LPD) or 3-dimensional robotic surgery (RPD), is still under debate. The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes.
- Being tested
- ERAMIP
- Keywords
- pancreatic surgery; neoplasms
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAMIPProcedure or surgery
3D-LPD with stented umbrella-pancreaticogastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES)
| Study group | Role | What they receive |
|---|---|---|
| ERAMIP with EEN | Minimally invasive pancreaticoduodenectomy (MIPD) with stented pancreatic-gastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES). All patients are submitted to an ERAS trajectory with EEN Receives: Procedure: ERAMIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe complications
Severe complications are classified according to the Clavien-Dindo Classification, i.e. Therapy Oriented Severity Grading Score of postoperative complications (TOSGS grade 3 or more): complication that needs interventional therapy under local or general anaesthesia
Measured: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 months
Secondary outcomes (1)
Postoperative in-hospital, 30-day and 90-day mortality
Postoperative mortality rate
Measured: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Neoplasms; Periampullary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baki Topal, University Hospital, Gasthuisberg
- Investigators
- Baki Topal, MD, PhD, Principal investigator, University Hospitals KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671357
- Sponsor's protocol ID
- ERAMIP
- Acronym
- ERAMIP
- Status last verified
- Mar 2020
- First submitted
- 22 Jan 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Topal B, Fieuws S, Aerts R, Weerts J, Feryn T, Roeyen G, Bertrand C, Hubert C, Janssens M, Closset J; Belgian Section of Hepatobiliary and Pancreatic Surgery. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial. Lancet Oncol. 2013 Jun;14(7):655-62. doi: 10.1016/S1470-2045(13)70126-8. Epub 2013 May 2.
PubMed 23643139Williamsson C, Karlsson N, Sturesson C, Lindell G, Andersson R, Tingstedt B. Impact of a fast-track surgery programme for pancreaticoduodenectomy. Br J Surg. 2015 Aug;102(9):1133-41. doi: 10.1002/bjs.9856. Epub 2015 Jun 4.
PubMed 26042725Topal H, Jaekers J, Geers J, Topal B. Prospective cohort study on short-term outcomes of 3D-laparoscopic pancreaticoduodenectomy with stented pancreaticogastrostomy. Surg Endosc. 2023 Feb;37(2):1203-1212. doi: 10.1007/s00464-022-09609-9. Epub 2022 Sep 26.
PubMed 36163561
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Minimally Invasive Pancreaticoduodenectomy With Stented Pancreaticogastrostomy and Roux-en-y Gastro-enterostomy
- ClinicalTrials.gov ID
- NCT02671357
- Acronym / sponsor ID
- ERAMIP / ERAMIP
- Keywords
- pancreatic surgery; neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 2 Feb 2016 (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.
This prospective observational cohort study aims to improve the postoperative course after minimally invasive pancreaticoduodenectomy (MIP) with stented pancreaticogastrostomy (sPG) for pancreatic head or peri-ampullary neoplasms. Patients are submitted to an enhanced recovery after surgery (ERAS) program with early enteral nutrition (EEN).
Detailed description
Pancreaticoduodenectomy (PD) is the standard of care for patients with malignant or benign disease of the pancreatic head or peri-ampullary region. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF) and/or delayed gastric emptying (DGE). In a recent multicentre randomized controlled trial, the investigators have shown pancreaticogastrostomy (PG; without a stent in the pancreatic duct) to be associated with 8% POPF rate, significantly lower than pancreaticojejunostomy (20%) (1). Since then, PG reconstruction is considered the standard of care in PD, which is also underlined in more recent systematic reviews.
In patients without POPF after PD, the length of hospital stay is determined by the occurrence of DGE, which is poorly understood and currently lacks any effective treatment. Patients who developed DGE after PD with PG anastomosis (n=18; 20%) had a significantly (p=0.014) longer (mean + sem) length of hospital stay (LOS) of 26.3 + 1.58 days, as compared to 22.4 + 1.27 days for patients without DGE (n=69). These figures are observed in the investigators' center as part of the multicentre RCT.
Enhanced recovery after surgery (ERAS) or fast-track (FT) programs are able to reduce postoperative length of hospital stay (LOS). Indeed recently, ERAS or FT programs have been implemented successfully in PD (2). Patients were discharged 4 days earlier in the ERAS group, without a negative effect on the clinical outcome. Still, many surgeons are reluctant to implement ERAS programs because they fear compromising patient safety.
In efforts to improve the outcomes of PD, many surgical techniques have been evaluated to restore the pancreatic digestive continuity after PD. However, the best way to ensure this and whether or not to perform the procedure via standard open or minimally invasive, i.e. 2- or 3-dimensional laparoscopic (3D-LPD) or 3-dimensional robotic surgery (RPD), is still under debate. The investigators have passed the learning curve of 50 3D-LPD and hypothesize the implementation of ERAS and EEN in 3D-LPD can improve short-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAMIP with EEN | – | Procedure: ERAMIPMinimally invasive pancreaticoduodenectomy (MIPD) with stented pancreatic-gastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES). All patients are submitted to an ERAS trajectory with EEN |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic or peri-ampullarf neoplasms to undergo minimally invasive pancreaticoduodenectomy
Key inclusion criteria (4 listed)
- Patients, male or female, who undergo MIP + sPG for a pancreatic or peri-ampullary tumor
- Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- Patients fit for minimally invasive pancreaticoduodenectomy (MIP)
- Informed consent signed
Key exclusion criteria (5 listed)
- Pregnancy
- MIP for pancreatic trauma
- MIP for complications of endoscopic retrograde cholangio-pancreaticography (ERCP)
- Reconstruction of the portal vein or superior mesenteric vein
- Any arterial reconstruction at the time of surgery
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 |
|---|---|---|
| ERAMIP3D-LPD with stented umbrella-pancreaticogastrostomy \& Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES) | Procedure or surgery | ERAMIP with EEN |
Primary outcome
The incidence of severe complications
Time frame: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 months
Severe complications are classified according to the Clavien-Dindo Classification, i.e. Therapy Oriented Severity Grading Score of postoperative complications (TOSGS grade 3 or more): complication that needs interventional therapy under local or general anaesthesia
1 secondary outcome
Postoperative in-hospital, 30-day and 90-day mortality
Time frame: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 month
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 26 Mar 2020.
- Background: PubMed 23643139Topal B, Fieuws S, Aerts R, Weerts J, Feryn T, Roeyen G, Bertrand C, Hubert C, Janssens M, Closset J; Belgian Section of Hepatobiliary and Pancreatic Surgery. Pancreaticojejunostomy versus pancreaticogastrostomy reconstruction after pancreaticoduodenectomy for pancreatic or periampullary tumours: a multicentre randomised trial. Lancet Oncol. 2013 Jun;14(7):655-62. doi: 10.1016/S1470-2045(13)70126-8. Epub 2013 May 2.
- Background: PubMed 26042725Williamsson C, Karlsson N, Sturesson C, Lindell G, Andersson R, Tingstedt B. Impact of a fast-track surgery programme for pancreaticoduodenectomy. Br J Surg. 2015 Aug;102(9):1133-41. doi: 10.1002/bjs.9856. Epub 2015 Jun 4.
- Derived from this study: PubMed 36163561Topal H, Jaekers J, Geers J, Topal B. Prospective cohort study on short-term outcomes of 3D-laparoscopic pancreaticoduodenectomy with stented pancreaticogastrostomy. Surg Endosc. 2023 Feb;37(2):1203-1212. doi: 10.1007/s00464-022-09609-9. Epub 2022 Sep 26.
- Individual participant dataSharing planned: No
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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 principal investigator
University Hospitals 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 Pancreatic Neoplasms; Periampullary Neoplasms, run by University Hospital, Gasthuisberg 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 4 inclusion and 5 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 26 Mar 2020. 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 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?
The incidence of severe complications (time frame: From date of pancreaticoduodenectomy until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 3 months). 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 NCT02671357, which also lists 3 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 26 Mar 2020.