Gastric CancerSCARNCT01257711
A Study Comparing Billroth II With Roux-en-Y Reconstruction for Gastric Cancer
A study testing Roux-en-Y or Billroth II in people with Gastric Cancer and Stomach Cancer, run by National Healthcare Group, Singapore at 4 sites in 2 countries.
Trial summary
Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal gastrectomy, however the debate one which is better remains unanswered. The aim of this study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal subtotal gastrectomy for gastric cancer in terms… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Gastric Cancer, Stomach Cancer, Gastrectomy
- What is being tested?
- Roux-en-Y or Billroth II
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Oct 2008to 12 Feb 2020
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient able to give informed consent
- Age 21 - 80 years both male \& females
- Patients with histopathologically confirmed adenocarcinoma of the distal lesser curve, distal greater curve, incisura and antrum that are deemed suitable for elective radical subtotal gastrectomy with curative intent.
Who cannot join
- Unable to give informed consent
- Patients who have undergone previous gastrectomy
- Patients with stomach cancer or previous small bowel surgery precluding construction of either form of anastomosis thus preventing randomization.
- Patients operated for palliation of gastric outlet obstruction, bleeding, perforation and obstruction
- Emergency gastrectomy for complications related to tumor.
- Patients with early gastric cancer who can have curative treatment by endoscopic methods.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Singapore3 sites
National University Hospital
Kent Ridge, 119074
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore, 529889
About this study
Official title: A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer
Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal gastrectomy, however the debate one which is better remains unanswered. The aim of this study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms and reflux problems when compared to Billroth II reconstruction. Patients with resectable gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected. They will be randomized after completion of distal subtotal gastrectomy to under go either Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively.
At 6 months follow up a repeat nutritional assessment using clinical and biochemical parameters will be carried out. The biochemical markers are part of routine follow up. The final assessment will be at the one year post surgery visit when by interview using EORTC 30 questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and surgery data for recurrence will be repeated. At one year patients will also have upper gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis will be graded and esophageal reflux assessed as per Los Angeles classification. It is postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for mortality and lost to follow up, a total of 160 subjects to be randomized equally will be recruited.
Read the detailed description
Subtotal distal gastrectomy with lymphadenectomy offers the best chance of cure either alone or in conjunction with other modalities for patients with operable distal gastric cancer. After a subtotal gastrectomy the gastrointestinal continuity can be restored by various techniques. Billroth I, Billroth II and Roux-en-Y reconstruction are all acceptable procedure with each having its merits and demerits. The choice of reconstructive procedure varies depending on individual Surgeons preference and institutional practice. There is geographical difference in practice with majority of surgeons in the east favoring Billroth I, while in the west; Roux-en-Y is more commonly employed (1). Billroth I vs Roux-en-Y reconstruction has been extensively studied with a prospective series by Sounya Nunobe et al that reported superior symptomatic and functional outcomes of Roux-en-Y procedure (2). However a randomised trial by Makoto Ishikawa et al found limited advantages of Roux-en-Y over Billroth I reconstruction (3). In this study Roux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Another reason that some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome (4,5). Billroth II reconstruction in comparison to Roux-en-Y is a simpler operation with only one anastomosis and faster operating time (6). This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has been criticized for increased reflux associated problem like esophagitis and gastritis, also noteworthy are risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures (7).
- Conditions
- Gastric Cancer, Stomach Cancer, Gastrectomy
- Being tested
- Roux-en-Y or Billroth II
- Keywords
- Gastric Cancer, Gastrectomy, Billroth 2, Roux-en-Y
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-Y or Billroth IIProcedure or surgery
Also called Reconstruction
Roux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome. Billroth II reconstruction is a simpler operation with only one anastomosis and faster operating time. This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has increased reflux associated problem like esophagitis and gastritis, risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures.
| Study group | Role | What they receive |
|---|---|---|
| Billroth II reconstruction | Other | Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Billroth II reconstruction. Receives: Procedure: Roux-en-Y or Billroth II |
| Roux-en-Y reconstruction | Other | Following Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Roux-en-Y reconstruction. Receives: Procedure: Roux-en-Y or Billroth II |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of this study is to compare Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes.
The outcomes include postoperative gastrointestinal symptoms, nutritional status, gastritis and/or esophagitis on endoscopy and quality of life up to one year after surgery. With the results, we can have a scientific basis in choosing the more suitable method of reconstruction for our patients.
Measured: 1 year
Secondary outcomes (4)
Quality of life pre and post operatively will be compared between Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy.
Symptomatic outcomes of both procedures have significant bearing on quality of life of patients and at the end be able to identify the better among the two procedure.
Measured: 1 year
Gastrointestinal symptoms assessment
Grading of clinical symptom is based on the total score of the the five items epigastric pain, heartburn, vomiting bile, postprandial bloating and nausea)pre and post operatively at 1 year. The higher the grade the poorer the outcome.
Measured: 1 year
Assessing nutritional status
Biochemical parameters as well as the height and weight of patients are measured pre operatively, 6 months and 1 year post operatively to compute the BMI. The nutrition assessment are scored by using the NRI and total lymphocyte count.
Measured: 1 year
Grading of gastritis and/or esophagitis on endoscopy
Endoscopic classification of inflammation of the remnant stomach to be graded one year after surgery. The gastritis will be reported according to the updated Sydney classification with the morphologic pattern, etiology \& topography being reported.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study start9 Oct 2008
- Primary completion31 Jul 2019
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Healthcare Group, Singapore
- Sponsor type
- Other government
- Collaborators
- Tan Tock Seng Hospital, Changi General Hospital, Chinese University of Hong Kong
- Responsible party
- Principal investigator, Asim Shabbir, National Healthcare Group, Singapore
- Investigators
- Asim Shabbir, MBBS, Principal investigator, National University Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257711
- Sponsor's protocol ID
- B/08/333
- Acronym
- SCAR
- Status last verified
- Mar 2021
- First submitted
- 8 Jun 2010
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Woodward A, Sillin LF, Wojtowycz AR, Bortoff A. Gastric stasis of solids after Roux gastrectomy: is the jejunal transection important? J Surg Res. 1993 Sep;55(3):317-22. doi: 10.1006/jsre.1993.1148.
PubMed 8412117Mathias JR, Fernandez A, Sninsky CA, Clench MH, Davis RH. Nausea, vomiting, and abdominal pain after Roux-en-Y anastomosis: motility of the jejunal limb. Gastroenterology. 1985 Jan;88(1 Pt 1):101-7. doi: 10.1016/s0016-5085(85)80140-2.
PubMed 3964759Yoshino K. [History of gastric cancer surgery]. Nihon Geka Gakkai Zasshi. 2000 Dec;101(12):855-60. Japanese.
PubMed 11201113Fukuhara K, Osugi H, Takada N, Takemura M, Higashino M, Kinoshita H. Reconstructive procedure after distal gastrectomy for gastric cancer that best prevents duodenogastroesophageal reflux. World J Surg. 2002 Dec;26(12):1452-7. doi: 10.1007/s00268-002-6363-z. Epub 2002 Oct 10.
PubMed 12370787Osugi H, Fukuhara K, Takada N, Takemura M, Kinoshita H. Reconstructive procedure after distal gastrectomy to prevent remnant gastritis. Hepatogastroenterology. 2004 Jul-Aug;51(58):1215-8.
PubMed 15239282Nunobe S, Okaro A, Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Billroth 1 versus Roux-en-Y reconstructions: a quality-of-life survey at 5 years. Int J Clin Oncol. 2007 Dec;12(6):433-9. doi: 10.1007/s10147-007-0706-6. Epub 2007 Dec 21.
PubMed 18071862Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
PubMed 16240061
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study Comparing Billroth II With Roux-en-Y Reconstruction After Radical Distal Subtotal Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT01257711
- Acronym / sponsor ID
- SCAR / B/08/333
- Conditions
- Gastric Cancer, Stomach Cancer, Gastrectomy
- Keywords
- Gastric Cancer, Gastrectomy, Billroth 2, Roux-en-Y
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- National Healthcare Group, SingaporeOther government
- Collaborators
- Tan Tock Seng Hospital, Changi General Hospital, Chinese University of Hong Kong
- Study start
- 9 Oct 2008 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 10 Dec 2010 (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.
Both Billroth II and Roux en Y are acceptable techniques of reconstruction after subtotal gastrectomy, however the debate one which is better remains unanswered. The aim of this study is to compare Billroth II and Roux en Y reconstruction techniques after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes and quality of life. The investigators hypothesize that Roux en Y will have lesser gastrointestinal symptoms and reflux problems when compared to Billroth II reconstruction. Patients with resectable gastric cancer meeting the inclusion criteria will be consented and enrolled. Data on demographics, nutrition, gastrointestinal symptoms, and quality of life will be collected. They will be randomized after completion of distal subtotal gastrectomy to under go either Roux en Y or Billroth II reconstruction. Surgery data will be collected post-operatively.
At 6 months follow up a repeat nutritional assessment using clinical and biochemical parameters will be carried out. The biochemical markers are part of routine follow up. The final assessment will be at the one year post surgery visit when by interview using EORTC 30 questionnaire quality of life data, gastrointestinal symptoms and nutritional assessment and surgery data for recurrence will be repeated. At one year patients will also have upper gastrointestinal endoscopy, which is part of routine follow up. At endoscopy stump gastritis will be graded and esophageal reflux assessed as per Los Angeles classification. It is postulated that 5% of the patients on Roux en Y reconstruction will experience poor clinical symptoms compared to 25% of those on Billroth II based on reflux symptoms. To achieve a statistical significance with 95% power and a 2-sided test of 5% for this 20% clinical difference, 80 subjects for each arm will be required. Factoring a 10% attrition rate for mortality and lost to follow up, a total of 160 subjects to be randomized equally will be recruited.
Detailed description
Subtotal distal gastrectomy with lymphadenectomy offers the best chance of cure either alone or in conjunction with other modalities for patients with operable distal gastric cancer. After a subtotal gastrectomy the gastrointestinal continuity can be restored by various techniques. Billroth I, Billroth II and Roux-en-Y reconstruction are all acceptable procedure with each having its merits and demerits. The choice of reconstructive procedure varies depending on individual Surgeons preference and institutional practice. There is geographical difference in practice with majority of surgeons in the east favoring Billroth I, while in the west; Roux-en-Y is more commonly employed (1). Billroth I vs Roux-en-Y reconstruction has been extensively studied with a prospective series by Sounya Nunobe et al that reported superior symptomatic and functional outcomes of Roux-en-Y procedure (2). However a randomised trial by Makoto Ishikawa et al found limited advantages of Roux-en-Y over Billroth I reconstruction (3). In this study Roux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Another reason that some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome (4,5). Billroth II reconstruction in comparison to Roux-en-Y is a simpler operation with only one anastomosis and faster operating time (6). This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has been criticized for increased reflux associated problem like esophagitis and gastritis, also noteworthy are risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures (7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Billroth II reconstruction | Other | Procedure: Roux-en-Y or Billroth IIFollowing Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Billroth II reconstruction. |
| Roux-en-Y reconstruction | Other | Procedure: Roux-en-Y or Billroth IIFollowing Radical Distal Subtotal Gastrectomy, patient will be randomised to restore the continuity of the intestine with the stomach using Roux-en-Y reconstruction. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient able to give informed consent
- Age 21 - 80 years both male \& females
- Patients with histopathologically confirmed adenocarcinoma of the distal lesser curve, distal greater curve, incisura and antrum that are deemed suitable for elective radical subtotal gastrectomy with curative intent.
Key exclusion criteria (6 listed)
- Unable to give informed consent
- Patients who have undergone previous gastrectomy
- Patients with stomach cancer or previous small bowel surgery precluding construction of either form of anastomosis thus preventing randomization.
- Patients operated for palliation of gastric outlet obstruction, bleeding, perforation and obstruction
- Emergency gastrectomy for complications related to tumor.
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 |
|---|---|---|
| Roux-en-Y or Billroth IIAlso: ReconstructionRoux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome. Billroth II reconstruction is a simpler operation with only one anastomosis and faster operating time. This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has increased reflux associated problem like esophagitis and gastritis, risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures. | Procedure or surgery | Billroth II reconstruction, Roux-en-Y reconstruction |
Primary outcome
The aim of this study is to compare Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes.
Time frame: 1 year
The outcomes include postoperative gastrointestinal symptoms, nutritional status, gastritis and/or esophagitis on endoscopy and quality of life up to one year after surgery. With the results, we can have a scientific basis in choosing the more suitable method of reconstruction for our patients.
4 secondary outcomes
Quality of life pre and post operatively will be compared between Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy.
Time frame: 1 year
Gastrointestinal symptoms assessment
Time frame: 1 year
Assessing nutritional status
Time frame: 1 year
Grading of gastritis and/or esophagitis on endoscopy
Time frame: 1 year
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 9 Mar 2021.
- Background: PubMed 8412117Woodward A, Sillin LF, Wojtowycz AR, Bortoff A. Gastric stasis of solids after Roux gastrectomy: is the jejunal transection important? J Surg Res. 1993 Sep;55(3):317-22. doi: 10.1006/jsre.1993.1148.
- Background: PubMed 3964759Mathias JR, Fernandez A, Sninsky CA, Clench MH, Davis RH. Nausea, vomiting, and abdominal pain after Roux-en-Y anastomosis: motility of the jejunal limb. Gastroenterology. 1985 Jan;88(1 Pt 1):101-7. doi: 10.1016/s0016-5085(85)80140-2.
- Background: PubMed 11201113Yoshino K. [History of gastric cancer surgery]. Nihon Geka Gakkai Zasshi. 2000 Dec;101(12):855-60. Japanese.
- Background: PubMed 12370787Fukuhara K, Osugi H, Takada N, Takemura M, Higashino M, Kinoshita H. Reconstructive procedure after distal gastrectomy for gastric cancer that best prevents duodenogastroesophageal reflux. World J Surg. 2002 Dec;26(12):1452-7. doi: 10.1007/s00268-002-6363-z. Epub 2002 Oct 10.
- Results publication: PubMed 15239282Osugi H, Fukuhara K, Takada N, Takemura M, Kinoshita H. Reconstructive procedure after distal gastrectomy to prevent remnant gastritis. Hepatogastroenterology. 2004 Jul-Aug;51(58):1215-8.
- Results publication: PubMed 18071862Nunobe S, Okaro A, Sasako M, Saka M, Fukagawa T, Katai H, Sano T. Billroth 1 versus Roux-en-Y reconstructions: a quality-of-life survey at 5 years. Int J Clin Oncol. 2007 Dec;12(6):433-9. doi: 10.1007/s10147-007-0706-6. Epub 2007 Dec 21.
- Results publication: PubMed 16240061Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
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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.
Asim Shabbir, MBBS principal investigator
National University Hospital System
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-Y or Billroth II in people with Gastric Cancer and Stomach Cancer, run by National Healthcare Group, Singapore at 4 sites in 2 countries.
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 3 inclusion and 6 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 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore, Hong Kong. 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 aim of this study is to compare Billroth II and Roux En Y reconstruction after radical distal subtotal gastrectomy for gastric cancer in terms of postoperative outcomes. (time frame: 1 year). 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 NCT01257711, which also lists 7 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 9 Mar 2021.