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HemoglobinsNCT05506748

Association Between Preoperative HALP and Immediate Postoperative Outcomes

An observational study of Hemoglobins and Albumins, run by Chitwan Medical College at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor… Read more about this study

Who is it for?
Ages 15 to 80 years
Conditions the study is for
Hemoglobins, Albumins, Platelets
What is being tested?
pantients undergoing pancreaticoduodenectomy
How many people
22 participants
Where
1 siteNepal
Study dates
20 Apr 2021to 20 Apr 2022
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 15 to 80 years
  • All sexes
  • Child, Adult, Older adult

Study population: All the cases of elective pancreaticoduodenectomy with combined "Artery First with Posterior and Uncinate approach" for malignant pancreatic head disease (ampullary, HOP, dCCA, duodenal In the Department of Surgery at BPKMCH between April 2021 to April 2022.

Who may be able to join

  • 1. All the cases of elective pancreaticoduodenectomies for malignant pancreatic head disease

Who cannot join

  • Incomplete clinicopathological and follow-up data,
  • Age <15 years and age >80 years
  • History of antitumor treatments, and
  • Record of other malignant tumors, (unresectable?)

Trial locations and contacts

1 site in 1 country.

Nepal1 site

  • Chitwan Medical College Teaching Hospital

    Bharatpur, Bagmati, 44207

Other trials in Nepal

About this study

Official title: Association Between Preoperative HALP and Immediate Postoperative Outcomes in Patients Undergoing Pancreaticoduodenectomy

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality.

Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

Read the detailed description

General Objective:

To assess the association between preoperative HALP and immediate postoperative outcome among patients undergoing PD.

Specific Objectives:

  1. To identify the magnitude of immediate post-operative morbidity and mortality in patients undergoing PD.
  2. To evaluate the descriptive measurement of preoperative Hemoglobin, Albumin, Lymphocytes, Platelets and HALP among patients undergoing PD.
  3. To compare the preoperative HALP with morbidity and mortality among patients undergoing PD.

Operational Definition:

  1. Immediate postoperative time - was taken as 30days following surgery.
  2. Morbidity- was defined by Clavién-Dindo20 grading for the surgical complication and DGE,21 POPF,22 and PPH23 -according to International Study Group of Pancreatic Surgery (ISGPS) grading.
  3. Mortality- survival within 30days.
  4. Level of preoperative HALP- normality test was done via SPSS and data of HALP followed normal Gaussian distribution. So, mean was used for the calculation of cut off value as 35.83. And, patients were divided into low HALP (≤35.83) group and high HALP (>35.83) group respectively
Being tested
pantients undergoing pancreaticoduodenectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pantients undergoing pancreaticoduodenectomyOther

    The study includes all the cases who underwent pancreaticoduodenectomy for carcinoma head of the pancreas, distal cholangiocarcinoma, periampullary and duodenal cancer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morbidity- Clavién-Dindo grading :

    It is graded from grade I to V on the basis of surgical site infection, organ space infection, single or multiple organ failure, and death.

    Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions

    Grade II Requires pharmacological treatment, blood transfusions, or total parenteral nutrition

    Grade III Requires surgical, endoscopic, or radiological intervention IIIa Not under general anesthesia IIIb Under general anesthesia

    Grade IV Life-threatening complication requiring IC/ICU management IVa Single organ dysfunction IVb Multiorgan dysfunction

    Grade V Death of a patient

    PS- Higher the score worst the outcome.

    Measured: 30days following the pancreaticoduodenectomy

  2. Morbidity- Delayed Gastric Empty (DGE)

    Postoperative gastroparesis.

    Grade A DGE: If the Naso-Gastric Tube (NGT) is needed between the postoperative day (POD) -4 and 7, or if reinserted due to nausea and vomiting after removal by POD 3 and the patient is unable to tolerate a solid diet on POD 7, but starts a solid diet before POD 14.

    Grade B DGE: If the NGT is needed from POD 8-14, if reinserted after POD 7, or if the patient cannot tolerate unlimited oral intake by POD 14, but is able to resume a solid diet before POD 21.

    Grade C DGE: When nasogastric intubation cannot be discontinued or has to be reinserted after POD 14, or if the patient is unable to maintain unlimited oral intake by POD 21.

    PS- Higher the score worst the outcome.

    Measured: 30days following the pancreaticoduodenectomy

  3. Morbidity- Postoperative pancreatic fistula (POPF)

    A POPF is an abnormal communication between the pancreatic ductal epithelium and another epithelial surface containing pancreas-derived enzyme-rich fluid.

    Biochemical leak (Grade A): Pancreatic fistula often appears well and requires no intervention.

    Grade B: Pancreatic fistulas occur in patients who generally appear well, but may require parenteral nutrition or interventional fistula drainage for the fistula to heal.

    Grade C: Pancreatic fistulas, in which patients appear ill and require parenteral nutrition, interventional drainage, and potentially even re-operation for treatment.

    PS- Higher the score worst the outcome.

    Measured: 30days following the pancreaticoduodenectomy

  4. Morbidity- Post pancreatectomy Hemorrhage (PPH)

    Time of onset

    • Early hemorrhage ( 24 h after the end of the index operation)
    • Late hemorrhage ( 24 h after the end of the index operation)

    Location

    • Intraluminal
    • Extraluminal

    Severity of Hemorrhage Mild

    • Small or medium volume blood loss (from drains, nasogastric tube, or on ultrasonography, decrease in hemoglobin concentration 3 g/dl)
    • Mild clinical impairment of the patient, no therapeutic consequence, or at most the need for noninvasive treatment with volume resuscitation or blood transfusions (2-3 units packed cells within 24hrs of end of operation or 1-3 units if later than 24hrs after operation)
    • No need for reoperation or interventional angiographic embolization; endoscopic treatment of anastomotic bleeding may occur provided the other conditions apply

    Severe

    • Large volume blood loss (drop in hemoglobin level by 3g/dl)
    • Clinically significant impairment and need for blood transfusion (3 units packed cells)
    • Need for invasive treatment.

    Measured: 30days following the pancreaticoduodenectomy

  5. Mortality

    Survival within 30days.

    Measured: 30days following the pancreaticoduodenectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start20 Apr 2021
  3. Primary completion20 Apr 2022
  4. Study completion20 Apr 2022

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05506748
Sponsor's protocol ID
078/079-103
Status last verified
Aug 2022
First submitted
12 Aug 2022
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD can be shared in view of the progress of medical research. An interested person should contact the primary investigator.

Publications

  • Ruiz-Tovar J, Martin-Perez E, Fernandez-Contreras ME, Reguero-Callejas ME, Gamallo-Amat C. Impact of preoperative levels of hemoglobin and albumin on the survival of pancreatic carcinoma. Rev Esp Enferm Dig. 2010 Nov;102(11):631-6. doi: 10.4321/s1130-01082010001100003.

    PubMed 21142383

  • Shirai Y, Shiba H, Haruki K, Horiuchi T, Saito N, Fujiwara Y, Sakamoto T, Uwagawa T, Yanaga K. Preoperative Platelet-to-Albumin Ratio Predicts Prognosis of Patients with Pancreatic Ductal Adenocarcinoma After Pancreatic Resection. Anticancer Res. 2017 Feb;37(2):787-793. doi: 10.21873/anticanres.11378.

    PubMed 28179331

  • Xu SS, Li S, Xu HX, Li H, Wu CT, Wang WQ, Gao HL, Jiang W, Zhang WH, Li TJ, Ni QX, Liu L, Yu XJ. Haemoglobin, albumin, lymphocyte and platelet predicts postoperative survival in pancreatic cancer. World J Gastroenterol. 2020 Feb 28;26(8):828-838. doi: 10.3748/wjg.v26.i8.828.

    PubMed 32148380

  • Gao X, Lin B, Lin Q, Ye T, Zhou T, Hu M, Zhu H, Lu F, Chen W, Xia P, Zhang F, Yu Z. A HALP score-based prediction model for survival of patients with the upper tract urothelial carcinoma undergoing radical nephroureterectomy. Bosn J Basic Med Sci. 2022 Apr 1;22(2):280-290. doi: 10.17305/bjbms.2021.6543.

    PubMed 35020581

  • Guo Y, Shi D, Zhang J, Mao S, Wang L, Zhang W, Zhang Z, Jin L, Yang B, Ye L, Yao X. The Hemoglobin, Albumin, Lymphocyte, and Platelet (HALP) Score is a Novel Significant Prognostic Factor for Patients with Metastatic Prostate Cancer Undergoing Cytoreductive Radical Prostatectomy. J Cancer. 2019 Jan 1;10(1):81-91. doi: 10.7150/jca.27210. eCollection 2019.

    PubMed 30662528

  • Wang X, He Q, Liang H, Liu J, Xu X, Jiang K, Zhang J. A novel robust nomogram based on preoperative hemoglobin and albumin levels and lymphocyte and platelet counts (HALP) for predicting lymph node metastasis of gastric cancer. J Gastrointest Oncol. 2021 Dec;12(6):2706-2718. doi: 10.21037/jgo-21-507.

    PubMed 35070400

  • Leetanaporn K, Hanprasertpong J. Predictive Value of the Hemoglobin-Albumin-Lymphocyte-Platelet (HALP) Index on the Oncological Outcomes of Locally Advanced Cervical Cancer Patients. Cancer Manag Res. 2022 Jun 14;14:1961-1972. doi: 10.2147/CMAR.S365612. eCollection 2022.

    PubMed 35726336

  • 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.

    PubMed 28040257

  • Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001.

    PubMed 17629996

  • 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.

    PubMed 17981197

  • Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

    PubMed 19638912

  • Hoshimoto S, Hishinuma S, Shirakawa H, Tomikawa M, Ozawa I, Ogata Y. Validation and clinical usefulness of pre- and postoperative systemic inflammatory parameters as prognostic markers in patients with potentially resectable pancreatic cancer. Pancreatology. 2020 Mar;20(2):239-246. doi: 10.1016/j.pan.2019.12.004. Epub 2019 Dec 14.

    PubMed 31862230

  • Afaneh C, Gerszberg D, Slattery E, Seres DS, Chabot JA, Kluger MD. Pancreatic cancer surgery and nutrition management: a review of the current literature. Hepatobiliary Surg Nutr. 2015 Feb;4(1):59-71. doi: 10.3978/j.issn.2304-3881.2014.08.07.

    PubMed 25713805

Questions about this trial

What is this clinical trial studying?

An observational study of Hemoglobins and Albumins, run by Chitwan Medical College at 1 site in Nepal.

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 4 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 18 Aug 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 Nepal. 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?

Morbidity- Clavién-Dindo grading : (time frame: 30days following the pancreaticoduodenectomy). The study lists 5 primary outcomes in all. 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 NCT05506748, which also lists 13 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 18 Aug 2022.

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