Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Pancreatic Cancer Clinical Trial

Official title:

Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418739
• Other study ID #: JEP-2019-796
• Status: Recruiting
• Phase: Phase 2
• Start date: January 27, 2020
• Est. completion date: November 26, 2022

Study information

• Verified date: June 2022
• Source: Universiti Kebangsaan Malaysia Medical Centre
• Contact: Ian Chik
• Phone: +60123243404
• Email: ianchikmd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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:

i. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: November 26, 2022
• Est. primary completion date: November 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients undergoing pancreaticoduodenectomy that can consent to the study

Exclusion Criteria:

• Patients with known allergy to human albumin

• Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.

Related Conditions & MeSH terms

• Anastomotic Leak
• Delayed Gastric Emptying
• Fistula
• Gastroparesis
• Pancreatic Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms
• Pancreaticoduodenectomy

Intervention

Drug:
• Human albumin
Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour

Locations

Country	Name	City	State
Malaysia	Universiti Kebangsaan Malaysia Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Kebangsaan Malaysia Medical Centre

Country where clinical trial is conducted

Malaysia, 

References & Publications (12)

Bassi 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 — View Citation

Boldt J. Use of albumin: an update. Br J Anaesth. 2010 Mar;104(3):276-84. doi: 10.1093/bja/aep393. Epub 2010 Jan 24. Review. Retraction in: Br J Anaesth. 2020 Sep;125(3):417. — View Citation

Brandstrup B, Tønnesen H, Beier-Holgersen R, Hjortsø E, Ørding 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, Graungaa — View Citation

Dindo 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. — View Citation

Fischer 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 — View Citation

Lassen K, Coolsen MM, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer M, Parks RW, Fearon KC, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CH; ERAS® Society; European Society for Clinical Nutrition and Metabolism; International Association for — View Citation

Lavu 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% hyperton — View Citation

Laxenaire 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. French. — View Citation

Ling, 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), 10

Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977 Feb 26;1(8009):466-9. — View Citation

Soar J, Pumphrey R, Cant A, Clarke S, Corbett A, Dawson P, Ewan P, Foëx 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 Cou — View Citation

Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pan — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Length of Hospital Stay	Duration of days of hospitalization	From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Secondary	Length of ICU stay	Duration of stay in ICU (in days), where relevant	From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Secondary	Postoperative Pancreatic Fistula (POPF) rates	Rates of postoperative pancreatic fistula	From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Secondary	Delayed Gastric Emptying	Rates of prolonged gastroparesis	From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months
Secondary	Ease of surgery	Measured in duration of surgery (in hours & mins)	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