PancreaticoduodenectomyPhase 2NCT04418739
Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
A Phase 2 study testing Human albumin in people with Pancreaticoduodenectomy and Pancreatic Fistula, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreaticoduodenectomy, Pancreatic Fistula, Delayed Gastric Emptying
- What is being tested?
- Human albumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteMalaysia
- Study dates
- 27 Jan 2020to 26 Nov 2022
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing pancreaticoduodenectomy that can consent to the study
Who cannot join
- Patients with known allergy to human albumin
- Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Kebangsaan Malaysia Medical Center
Kuala Lumpur, 56000
Ian Chik, +60123243404, ianchikmd@gmail.com
Sarah I Liew, MBBS, +601112218229, liew4689@gmail.com
About this study
Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.
Read the detailed description
This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes. Primary endpoint will be overall complication rates whilst secondary endpoints are length of hospitalization, length of ICU care, duration of gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery and intraoperative bleeding.
Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic control and near-zero fluid balance.
Data collection will include:
- preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities and the New York Heart Association (NYHA) functional status classification. Further information will include biochemical markers such as serum albumin albumin, white cell count (WCC), renal functions. ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct size, pancreatic texture, amount and type of fluid administered, fluid balances and type of anastomoses. iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3, duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep vein thrombosis, re-operation, and mortality.
- Conditions
- Pancreaticoduodenectomy, Pancreatic Fistula, Delayed Gastric Emptying, Pancreatic Cancer, Anastomotic Leak
- Being tested
- Human albumin
- Keywords
- Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreatic Cancer, Intravenous Human Albumin
- Medical subject headings
- Pancreatic Fistula, Gastroparesis, Pancreatic Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albuminDrug
Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Standard intraoperative fluid regime |
| Treatment Arm | Experimental | Intravenous human albumin 1g/kg at skin incision running at 100ml/hour Receives: Drug: Human albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complications
Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.
Measured: Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.
Secondary outcomes (5)
Length of Hospital Stay
Duration of days of hospitalization
Measured: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Length of ICU stay
Duration of stay in ICU (in days), where relevant
Measured: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Postoperative Pancreatic Fistula (POPF) rates
Rates of postoperative pancreatic fistula
Measured: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Delayed Gastric Emptying
Rates of prolonged gastroparesis
Measured: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Ease of surgery
Measured in duration of surgery (in hours \& mins)
Measured: Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start27 Jan 2020
- Primary completion26 Nov 2022 (estimated)
- Study completion26 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Chik, Study chair, Universiti Kebangsaan Malaysia Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418739
- Sponsor's protocol ID
- JEP-2019-796
- Status last verified
- Jun 2022
- First submitted
- 25 Mar 2020
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.
PubMed 14578723Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Lassen 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; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.
PubMed 23079762Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
PubMed 25115420Boldt J. Use of albumin: an update. Br J Anaesth. 2010 Mar;104(3):276-84. doi: 10.1093/bja/aep393. Epub 2010 Jan 24.
PubMed 20100698Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977 Feb 26;1(8009):466-9. doi: 10.1016/s0140-6736(77)91953-5.
PubMed 65572Ling, Q. Y., Ariffin, A. C., Azman, A., Zuhdi, Z., Othman, H., & Jarmin, R. (2017). Early postoperative outcomes for pancreaticoduodenectomy before and after implementation of enhanced recovery after surgery (ERAS) protocol. Surgical Chronicles, 22(3), 109-113
Soar J, Pumphrey R, Cant A, Clarke S, Corbett A, Dawson P, Ewan P, Foex B, Gabbott D, Griffiths M, Hall J, Harper N, Jewkes F, Maconochie I, Mitchell S, Nasser S, Nolan J, Rylance G, Sheikh A, Unsworth DJ, Warrell D; Working Group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions--guidelines for healthcare providers. Resuscitation. 2008 May;77(2):157-69. doi: 10.1016/j.resuscitation.2008.02.001. Epub 2008 Mar 20.
PubMed 18358585Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PubMed 28040257Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.
PubMed 17981197Laxenaire MC, Charpentier C, Feldman L. [Anaphylactoid reactions to colloid plasma substitutes: incidence, risk factors, mechanisms. A French multicenter prospective study]. Ann Fr Anesth Reanim. 1994;13(3):301-10. doi: 10.1016/s0750-7658(94)80038-3. French.
PubMed 7992937Fischer M, Matsuo K, Gonen M, Grant F, Dematteo RP, D'Angelica MI, Mascarenhas J, Brennan MF, Allen PJ, Blumgart LH, Jarnagin WR. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg. 2010 Dec;252(6):952-8. doi: 10.1097/SLA.0b013e3181ff36b1.
PubMed 21107104
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes
- ClinicalTrials.gov ID
- NCT04418739
- Acronym / sponsor ID
- JEP-2019-796
- Conditions
- Pancreaticoduodenectomy, Pancreatic Fistula, Delayed Gastric Emptying, Pancreatic Cancer, Anastomotic Leak
- Keywords
- Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Pancreatic Cancer, Intravenous Human Albumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 26 Nov 2022 (estimated)
- Study completion
- 26 Nov 2022 (estimated)
- First posted
- 5 Jun 2020 (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.
Pancreaticoduodenectomy (PD), more commonly known as Whipple's surgery is the mainstay treatment for pancreatic head and periampullary cancer. Factors contributing to PD outcomes are broadly categorized to disease-related, patient-related and operative factors. Whereas an inexhaustible list of study exists on looking at reducing PD complication rates with respect to the above-mentioned factors, it was only recently that more attention has been given to the impact of perioperative and intraoperative fluid regimes on PD outcomes. This study takes interest in the impact of intraoperative fluid regimes on PD outcomes. The objective of this investigation is to compare the outcomes with the use of intraoperative intravenous human albumin versus standard intraoperative fluid regimes.
Detailed description
This is a randomized controlled trial being conducted at the Universiti Kebangsaan Malaysia Medical Center (UKMMC) with two arms; the control and treatment arms. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes. Primary endpoint will be overall complication rates whilst secondary endpoints are length of hospitalization, length of ICU care, duration of gastroparesis, pancreatic fistula rates, surgical site infection rates, duration of surgery and intraoperative bleeding.
Beyond the intraoperative fluid regimes, postoperative care follows the standardised UKMMC Enhanced Recovery After Surgery (ERAS) protocols which saw an improvement in overall outcomes in patients who underwent pancreaticoduodenectomies (PD). Preoperative care will include nutrition optimisation, counselling, antimicrobial prophylaxis, perioperative glycemic control and near-zero fluid balance.
Data collection will include:
- preoperative data: age, sex, ethnicity, BMI on admission, date of admission, comorbidities and the New York Heart Association (NYHA) functional status classification. Further information will include biochemical markers such as serum albumin albumin, white cell count (WCC), renal functions. ii. Intraoperative information: duration of surgery, estimated blood loss, pancreatic duct size, pancreatic texture, amount and type of fluid administered, fluid balances and type of anastomoses. iii. postoperative data: fluid balances and renal function of postoperative day 1 to 3, duration of ICU stay, readmission to ICU, length of hospital stay, duration to standard feeds, grading of pancreatic fistula (where relevant), surgical site infection, duration to removal of urinary catheter, cardiac complications, renal and pulmonary complications, deep vein thrombosis, re-operation, and mortality.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial conducted at the University Kebangsaan Malaysia Medical Center (UKMMC) with two arms; a control a treatment arm. The treatment arm will receive intravenous human albumin intraoperatively whilst the control arm will receive standard intraoperative fluid regimes.
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Standard intraoperative fluid regime |
| Treatment Arm | Experimental | Drug: Human albuminIntravenous human albumin 1g/kg at skin incision running at 100ml/hour |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing pancreaticoduodenectomy that can consent to the study
Key exclusion criteria (2 listed)
- Patients with known allergy to human albumin
- Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.
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 |
|---|---|---|
| Human albuminIntravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour | Drug | Treatment Arm |
Primary outcome
Overall Complications
Time frame: Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 months.
Complications are defined as any deviation from the normal postoperative course, graded from I to V following the Clavien-Dindo classification of complications whereby Grade I are mild complications not needing any additional interventions and Grade V equates to the most severe complication which is death.
5 secondary outcomes
Length of Hospital Stay
Time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Length of ICU stay
Time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Postoperative Pancreatic Fistula (POPF) rates
Time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Delayed Gastric Emptying
Time frame: From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Ease of surgery
Time frame: Duration is measured from the start time till the end time of surgery and will be assessed at the end of surgery for up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Results publication: PubMed 14578723Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8. doi: 10.1097/01.sla.0000094387.50865.23.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Results publication: PubMed 23079762Lassen 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; ERAS(R) Society; European Society for Clinical Nutrition and Metabolism; International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Clin Nutr. 2012 Dec;31(6):817-30. doi: 10.1016/j.clnu.2012.08.011. Epub 2012 Sep 26.
- Results publication: PubMed 25115420Lavu H, Sell NM, Carter TI, Winter JM, Maguire DP, Gratch DM, Berman RA, Feil MG, Grunwald Z, Leiby BE, Pequignot EC, Rosato EL, Yeo CJ. The HYSLAR trial: a prospective randomized controlled trial of the use of a restrictive fluid regimen with 3% hypertonic saline versus lactated Ringers in patients undergoing pancreaticoduodenectomy. Ann Surg. 2014 Sep;260(3):445-53; discussion 453-5. doi: 10.1097/SLA.0000000000000872.
- Results publication: PubMed 20100698Boldt J. Use of albumin: an update. Br J Anaesth. 2010 Mar;104(3):276-84. doi: 10.1093/bja/aep393. Epub 2010 Jan 24.
- Results publication: PubMed 65572Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977 Feb 26;1(8009):466-9. doi: 10.1016/s0140-6736(77)91953-5.
- Results publicationLing, Q. Y., Ariffin, A. C., Azman, A., Zuhdi, Z., Othman, H., & Jarmin, R. (2017). Early postoperative outcomes for pancreaticoduodenectomy before and after implementation of enhanced recovery after surgery (ERAS) protocol. Surgical Chronicles, 22(3), 109-113
- Results publication: PubMed 18358585Soar J, Pumphrey R, Cant A, Clarke S, Corbett A, Dawson P, Ewan P, Foex B, Gabbott D, Griffiths M, Hall J, Harper N, Jewkes F, Maconochie I, Mitchell S, Nasser S, Nolan J, Rylance G, Sheikh A, Unsworth DJ, Warrell D; Working Group of the Resuscitation Council (UK). Emergency treatment of anaphylactic reactions--guidelines for healthcare providers. Resuscitation. 2008 May;77(2):157-69. doi: 10.1016/j.resuscitation.2008.02.001. Epub 2008 Mar 20.
- Results publication: PubMed 28040257Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Results publication: PubMed 17981197Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005.
- Results publication: PubMed 7992937Laxenaire MC, Charpentier C, Feldman L. [Anaphylactoid reactions to colloid plasma substitutes: incidence, risk factors, mechanisms. A French multicenter prospective study]. Ann Fr Anesth Reanim. 1994;13(3):301-10. doi: 10.1016/s0750-7658(94)80038-3. French.
- Results publication: PubMed 21107104Fischer M, Matsuo K, Gonen M, Grant F, Dematteo RP, D'Angelica MI, Mascarenhas J, Brennan MF, Allen PJ, Blumgart LH, Jarnagin WR. Relationship between intraoperative fluid administration and perioperative outcome after pancreaticoduodenectomy: results of a prospective randomized trial of acute normovolemic hemodilution compared with standard intraoperative management. Ann Surg. 2010 Dec;252(6):952-8. doi: 10.1097/SLA.0b013e3181ff36b1.
- 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.
Ian Chik study chair
Universiti Kebangsaan Malaysia Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human albumin in people with Pancreaticoduodenectomy and Pancreatic Fistula, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 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 16 Jun 2022. 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 Malaysia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ian Chik (+60123243404, ianchikmd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Complications (time frame: Postoperative complications are recorded from date of surgery to date of documented complications including death, assessed from date of surgery to date of discharge or death, whichever came earlier, for up to 12 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 NCT04418739, which also lists 12 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 16 Jun 2022.