Intravenous Human Albumin In Improving Pancreaticoduodenectomy Outcomes

NCT04418739 | Unknown Phase 2

• 1 other identifier: JEP-2019-796
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreaticoduodenectomy; Pancreatic Fistula; Delayed Gastric Emptying; Pancreatic Cancer; Anastomotic Leak

Keywords

Pancreaticoduodenectomy; Postoperative Pancreatic Fistula; Pancreatic Cancer; Intravenous Human Albumin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Length of Hospital Stay

  From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months

• Length of ICU stay

  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

  From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months

• Delayed Gastric Emptying

  From date of surgery to date of discharge or date of death, whichever came earlier, assessed up to 12 months

• Ease of surgery

  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

Study Arms (2)

Control Arm

NO INTERVENTION

Standard intraoperative fluid regime

Treatment Arm

EXPERIMENTAL

Intravenous human albumin 1g/kg at skin incision running at 100ml/hour

Drug: Human albumin

Interventions

Human albumin DRUG

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

Treatment Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing pancreaticoduodenectomy that can consent to the study

You may not qualify if:

• Patients with known allergy to human albumin
• Patients of American Society of Anaesthesiologist (ASA) physical status class 3 and above.

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Center

Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (12)

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  PMID: 14578723 RESULT

• 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. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 RESULT

• Lassen 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.

  PMID: 23079762 RESULT

• 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% 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.

  PMID: 25115420 RESULT

• 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.

  PMID: 20100698 RESULT

• Ring 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.

  PMID: 65572 RESULT

• 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), 109-113

  RESULT

• 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.

  PMID: 18358585 RESULT

• 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 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.

  PMID: 28040257 RESULT

• Wente 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.

  PMID: 17981197 RESULT

• 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. doi: 10.1016/s0750-7658(94)80038-3. French.

  PMID: 7992937 RESULT

• 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 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.

  PMID: 21107104 RESULT

MeSH Terms

Conditions

Pancreatic Fistula; Gastroparesis; Pancreatic Neoplasms; Anastomotic Leak

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Stomach Diseases; Gastrointestinal Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Endocrine System Diseases; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Officials

• Ian Chik

  Universiti Kebangsaan Malaysia Medical Center

  STUDY CHAIR

Central Study Contacts

Ian Chik

CONTACT

+60123243404; ianchikmd@gmail.com

Sarah I Liew

CONTACT

+601112218229; liew4689@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: June 5, 2020
• Study Start: January 27, 2020
• Primary Completion: November 26, 2022
• Study Completion: November 26, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)